co_sos
1 records
CO Business: BAXTER HEALTHCARE CORPORATION
1983-10-21
FPC | Status: Good Standing | Deerfield, IL
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EPA (Environmental Protection Agency)
7 records
epa_echo
3 records
EPA ECHO: BAXTER HEALTHCARE, INC.
1996-09-27
Penalty assessed: $85,000. Type: Administrative - Formal
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EPA ECHO: BAXTER HEALTHCARE CORP
1992-11-06
Penalty assessed: $50,000. Type: Administrative - Formal
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fda
449 records
FDA Device Recall: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570
2026-02-25
Class II — Pumps were released without full testing being performed, including occlusion alarm testing.
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FDA Drug Recall: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte
2026-02-04
Class II — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
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FDA Device Recall: SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
2026-01-28
Class II — Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device hav...
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FDA Recall: Baxter Healthcare Corporation — Class II
20251210
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bla | Product: Welch Allyn INF BAG, Thigh 1-Tube, Mod...
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FDA Recall: Baxter Healthcare Corporation — Class II
20251029
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temp | Product: Oral Probe (Product code 02893-000), a...
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FDA Recall: Baxter Healthcare Corporation — Class II
20251022
IV sets may leak. | Product: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 m
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FDA Recall: Baxter Healthcare Corporation — Class II
20251022
IV sets may leak. | Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backch
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FDA Recall: Baxter Healthcare Corporation — Class II
20251001
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports | Product: Baster Continu-Flo Solution Set, Non-V...
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FDA Recall: Baxter Healthcare Corporation — Class I
20250820
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioni | Product: Baxter Novum IQ Large Volume Pump, Pro...
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FDA Recall: Baxter Healthcare Corporation — Class II
20250423
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing th | Product: Welch Allyn Connex Vital Signs Monitor...
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FDA Recall: Baxter Healthcare Corporation — Class II
20250423
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | Product: Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr...
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FDA Recall: Baxter Healthcare Corporation — Class I
20250122
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes | Product: Welch Allyn, Inc., Life 2000 Ventilati...
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FDA Device Recall: Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product r
2025-12-10
Class II — Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
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FDA Device Recall: Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Pl
2025-10-29
Class II — Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may ...
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FDA Device Recall: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEA
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H85
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backc
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLE
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard
2025-10-22
Class II — IV sets may leak.
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FDA Device Recall: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves,
2025-10-01
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
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FDA Device Recall: Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
2025-09-10
Class I — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result...
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FDA Device Recall: Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
2025-09-10
Class I — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result...
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FDA Drug Recall: Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo con
2025-09-03
Class II — Discoloration
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FDA Device Recall: Spectrum IQ Infusion Pump, Product Code 3570009
2025-09-03
Class II — Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lea...
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FDA Device Recall: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
2025-08-20
Class I — Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rat...
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
2025-07-23
Class I — Certain Spectrum infusion pumps may have an incorrect version of software.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
2025-07-23
Class I — Certain Spectrum infusion pumps may have an incorrect version of software.
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FDA Device Recall: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope han
2025-06-18
Class II — The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive h...
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FDA Device Recall: Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
2025-06-18
Class II — Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes...
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FDA Device Recall: Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433,
2025-06-04
Class II — There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
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FDA Device Recall: Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
2025-05-28
Class I — There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
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FDA Device Recall: Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-000
2025-05-21
Class I — A cybersecurity vulnerability was discovered through internal testing.
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FDA Device Recall: Welch Allyn Connex Vital Signs Monitor (CVSM):
2025-04-23
Class II — There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that ...
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FDA Device Recall: Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Produ
2025-04-23
Class II — Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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FDA Device Recall: Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 7
2025-04-23
Class II — Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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FDA Device Recall: Welch Allyn CONNEX Accessory Power Management Stand:
2025-04-23
Class II — There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that ...
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FDA Device Recall: Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff lab
2025-04-23
Class II — Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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FDA Device Recall: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH AL
2025-04-23
Class II — Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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FDA Device Recall: Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-
2025-04-23
Class II — Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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FDA Device Recall: Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter Mobile column TruSystem 7500 U, Product Code 1730720
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter TruSystem 7500, Product Code 4091000
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter Stationary column TruSystem 7500, Product Code 1717020
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
2025-04-02
Class II — There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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FDA Device Recall: Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
2025-01-29
Class II — Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
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FDA Device Recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404
2025-01-29
Class II — Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
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FDA Device Recall: Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
2025-01-22
Class I — There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
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FDA Device Recall: Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
2025-01-22
Class I — There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Produ
2025-01-08
Class II — Devices were identified as released after repair without full testing being performed, which includes flow testing.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Produc
2025-01-08
Class II — Devices were identified as released after repair without full testing being performed, which includes flow testing.
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FDA Recall: Baxter Healthcare Corporation — Class II
20241204
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. | Product: Baxter MiniCap Extended Life PD Transfer Set...
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FDA Recall: Baxter Healthcare Corporation — Class II
20241204
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. | Product: Baxter MiniCap Extended Life PD Transfer Set...
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FDA Recall: Baxter Healthcare Corporation — Class II
20241113
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Arch | Product: Hillrom Welch Allyn Vision Express Hol...
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FDA Recall: Baxter Healthcare Corporation — Class II
20241113
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Arch | Product: Hillrom Welch Allyn Q-Stress Cardiac S...
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FDA Recall: Baxter Healthcare Corporation — Class II
20241030
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. | Product: Baxter Operating Table TruSystem 7000 (dV) V,...
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FDA Recall: Baxter Healthcare Corporation — Class I
20240925
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inl | Product: Baxter EXACTAMIX Inlet, Vented, Syring...
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FDA Recall: Baxter Healthcare Corporation — Class II
20240626
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the | Product: Centrella Max - The Centrella Smart+ B...
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FDA Recall: Baxter Healthcare Corporation — Class II
20240501
Product was distributed in the United States without proper regulatory approval. | Product: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic su
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FDA Recall: Baxter Healthcare Corporation — Class II
20240403
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin | Product: Baxter Supple Peri-Guard Repair Patch ...
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FDA Recall: Baxter Healthcare Corporation — Class II
20240117
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does no | Product: Baxter Flo-Thru Intraluminal Shunt, Pr...
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FDA Recall: Baxter Healthcare Corporation — Class II
20240117
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does no | Product: Baxter Floseal Hemostatic Matrix Fast ...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44
2024-12-04
Class II — There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44
2024-12-04
Class II — There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part
2024-12-04
Class II — There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44
2024-12-04
Class II — There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44
2024-11-27
Class I — Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated b...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C44
2024-11-27
Class I — Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated b...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4
2024-11-27
Class I — Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated b...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4
2024-11-27
Class I — Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated b...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4
2024-11-27
Class I — Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated b...
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FDA Device Recall: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35
2024-11-20
Class II — The door on the Spectrum IQ Infusion pump may not be able to fully close.
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FDA Drug Recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri
2024-11-13
Class II — Labeling: Missing Label
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FDA Device Recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
2024-11-13
Class II — There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) ...
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FDA Device Recall: Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
2024-11-13
Class II — There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) ...
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FDA Device Recall: Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagno
2024-11-13
Class II — There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) ...
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FDA Device Recall: a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P790
2024-11-06
Class II — The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through ...
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FDA Device Recall: Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton
2024-10-30
Class I — The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator bef...
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FDA Device Recall: Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Baxter Operating Table TruSystem 7000, Product code REF 1841046
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
2024-10-30
Class II — The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
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FDA Device Recall: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmac
2024-09-25
Class I — Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H93...
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FDA Device Recall: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pha
2024-09-25
Class I — Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H93...
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FDA Device Recall: Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a ph
2024-09-25
Class I — Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H93...
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FDA Drug Recall: Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,00
2024-09-11
Class I — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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FDA Device Recall: Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either
2024-08-28
Class II — The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Sp...
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FDA Device Recall: Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with
2024-08-28
Class II — The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Sp...
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
2024-08-14
Class II — Improperly performed testing prior to release
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FDA Device Recall: Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
2024-08-14
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives...
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FDA Device Recall: Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patie
2024-07-24
Class I — Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
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FDA Drug Recall: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose,
2024-07-17
Class II — Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
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FDA Device Recall: Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150
2024-07-17
Class II — During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect...
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FDA Device Recall: Braun Thermoscan¿ PRO 6000 Ear Thermometer
2024-07-17
Class II — The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
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FDA Device Recall: Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Li
2024-07-17
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed be...
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FDA Device Recall: iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Li
2024-07-17
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed be...
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FDA Device Recall: VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40281
2024-07-17
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed be...
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FDA Device Recall: Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life200
2024-07-03
Class I — Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger d...
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FDA Device Recall: Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare envir
2024-06-26
Class II — There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents con...
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FDA Device Recall: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abd
2024-05-01
Class II — Product was distributed in the United States without proper regulatory approval.
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FDA Device Recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe
2024-04-24
Class II — The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravasc...
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FDA Device Recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe
2024-04-24
Class II — The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravasc...
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FDA Device Recall: Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbe
2024-04-24
Class II — The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravasc...
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FDA Device Recall: Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed un
2024-04-17
Class II — Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
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FDA Device Recall: Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for p
2024-04-10
Class II — Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices ...
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FDA Device Recall: Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO,
2024-04-03
Class II — A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable ...
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FDA Device Recall: Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608,
2024-04-03
Class II — A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable ...
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FDA Device Recall: Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC
2024-04-03
Class II — A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable ...
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FDA Device Recall: Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) S
2024-04-03
Class II — A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable ...
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FDA Device Recall: HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position,
2024-03-27
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on...
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FDA Device Recall: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
2024-03-20
Class II — Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
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FDA Drug Recall: Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), Fo
2024-02-28
Class II — Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified t...
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FDA Device Recall: Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: XScribe CP Cardiac Stress Testing System, version 6, with below product names an
2024-01-17
Class II — Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
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FDA Device Recall: Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the follo
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404:
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071;
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.
2024-01-17
Class II — Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Inst...
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FDA Device Recall: Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
2023-12-20
Class II — There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
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FDA Drug Recall: Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufac
2023-12-13
Class II — Failed pH Specifications
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FDA Device Recall: HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031
2023-11-08
Class II — Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transp...
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FDA Drug Recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S
2023-10-25
Class II — CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
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FDA Device Recall: Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ver
2023-10-04
Class II — Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper...
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FDA Device Recall: Welch Allyn Connex Spot Monitor
2023-09-20
Class II — Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
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FDA Drug Recall: Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX
2023-09-06
Class II — Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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FDA Drug Recall: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, pack
2023-09-06
Class II — Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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FDA Drug Recall: Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx
2023-08-30
Class III — Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
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FDA Device Recall: GEM FLOW COUPLER Monitor, PN 5156-00000-011
2023-07-26
Class II — An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was sele...
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FDA Device Recall: The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700
2023-07-19
Class I — A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in...
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FDA Device Recall: Allen Advance Chest Support with Pad
2023-07-19
Class II — Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
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FDA Device Recall: NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
2023-07-05
Class II — Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be a...
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FDA Device Recall: Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centr
2023-07-05
Class II — Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be a...
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FDA Device Recall: Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 208
2023-05-10
Class II — There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
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FDA Drug Recall: Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-F
2023-05-03
Class II — Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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FDA Drug Recall: Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose,
2023-05-03
Class II — Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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FDA Device Recall: Automated Peritoneal Dialysis System. Used for automatic control of dialysis so
2023-04-05
Class II — The electrical safety testing was not properly performed on the impacted devices and additional testing is required
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FDA Device Recall: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory
2023-03-15
Class II — MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure ...
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FDA Device Recall: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilato
2023-03-08
Class I — There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
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FDA Recall: Baxter Healthcare Corporation — Class II
20221228
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Product: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hem...
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FDA Recall: Baxter Healthcare Corporation — Class II
20221228
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hem...
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FDA Recall: Baxter Healthcare Corporation — Class I
20221109
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bl | Product: Hillrom Hospital Bed Accessory, Watch ...
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FDA Recall: Baxter Healthcare Corporation — Class III
20221005
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. | Product: Starling Monitor, Product code CMMST5 and Starli...
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FDA Recall: Baxter Healthcare Corporation — Class II
20220831
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Product: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b)...
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FDA Recall: Baxter Healthcare Corporation — Class II
20220831
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. | Product: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compound
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FDA Recall: Baxter Healthcare Corporation — Class II
20220608
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. | Product: 3,65 m Extension Set with Luer-lock Connector
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FDA Recall: Baxter Healthcare Corporation — Class II
20220608
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. | Product: 15 Liters Drain Bag
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FDA Recall: Baxter Healthcare Corporation — Class II
20220511
There is a potential for foreign matter. | Product: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shun
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FDA Recall: Baxter Healthcare Corporation — Class II
20220330
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. | Product: Compella Therapy Air Supply Unit
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FDA Recall: Baxter Healthcare Corporation — Class II
20220216
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acet | Product: Baxter MiniCap Extended Life PD Transf...
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FDA Recall: Baxter Healthcare Corporation — Class II
20220216
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acet | Product: Baxter MiniCap Extended Life PD Transf...
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FDA Device Recall: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal
2022-12-28
Class II — Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
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FDA Device Recall: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal
2022-12-28
Class II — Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
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FDA Device Recall: Hill-Rom Progressa Bed System
2022-11-23
Class II — The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., howeve...
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FDA Device Recall: Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Pr
2022-11-09
Class I — Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, in...
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FDA Device Recall: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800
2022-11-09
Class II — the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
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FDA Device Recall: Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF
2022-11-09
Class II — the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
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FDA Device Recall: Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Ce
2022-11-09
Class I — Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, in...
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FDA Device Recall: Prismaflex HF20 Set (product code 109841). For use in providing continuous flui
2022-10-19
Class II — Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the ...
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FDA Device Recall: Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST1
2022-10-19
Class II — Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the ...
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FDA Device Recall: Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For u
2022-10-19
Class II — Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the ...
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FDA Device Recall: Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-
2022-10-05
Class III — Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
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FDA Device Recall: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code
2022-09-21
Class I — Firm noted an increase in customer reports of leaks.
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FDA Device Recall: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack
2022-08-31
Class II — There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
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FDA Device Recall: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corpor
2022-08-31
Class II — There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
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FDA Device Recall: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, RE
2022-08-31
Class II — There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
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FDA Device Recall: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, R
2022-08-31
Class II — There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
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FDA Device Recall: Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF
2022-08-31
Class II — There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
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FDA Drug Recall: Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag,
2022-08-24
Class II — Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled ...
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FDA Device Recall: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924A
2022-07-27
Class II — The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in...
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FDA Device Recall: Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
2022-07-27
Class II — The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in...
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FDA Device Recall: Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
2022-07-27
Class II — The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in...
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FDA Device Recall: NaviCare Nurse Call/Voalte Nurse Call
2022-07-06
Class II — An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100...
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FDA Device Recall: #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LE
2022-07-06
Class II — Packaging error.
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FDA Device Recall: 3,65 m Extension Set with Luer-lock Connector
2022-06-08
Class II — Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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FDA Device Recall: 15 Liters Drain Bag
2022-06-08
Class II — Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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FDA Device Recall: APD Drain Manifold
2022-06-08
Class II — Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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FDA Device Recall: In-Line ventilator adaptor
2022-06-08
Class I — There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
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FDA Device Recall: Locking Cap for PD Catheter Adapter
2022-06-08
Class II — Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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FDA Device Recall: In-Line ventilator adaptor
2022-06-08
Class I — There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
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FDA Device Recall: 5 Prong Manifold Set (with Luer Connectors)
2022-06-08
Class II — Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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FDA Device Recall: Voalte Nurse Call System provides a comprehensive communication and informati
2022-05-25
Class II — Firm discovered a firmware memory leak with a supplier-manufactured component.
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FDA Device Recall: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular proc
2022-05-11
Class II — There is a potential for foreign matter.
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FDA Device Recall: PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
2022-05-04
Class II — This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the ...
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FDA Device Recall: PrisMax System, Product Code 955724
2022-05-04
Class II — This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the ...
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FDA Device Recall: MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483,
2022-04-06
Class II — Devices distributed lacked regulatory clearance.
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FDA Device Recall: Compella Therapy Air Supply Unit
2022-03-30
Class II — Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
2022-02-16
Class II — Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone ...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4
2022-02-16
Class II — Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone ...
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FDA Device Recall: Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
2022-02-16
Class II — Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone ...
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FDA Device Recall: Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza
2022-02-16
Class II — Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone ...
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FDA Device Recall: Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
2022-02-09
Class I — There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and...
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FDA Recall: Baxter Healthcare Corporation — Class II
20211117
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the | Product: Hemodialysis Delivery System, Software...
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FDA Recall: Baxter Healthcare Corporation — Class II
20210908
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not | Product: Baxter prismaflex, HF 1000 PAES membra...
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FDA Recall: Baxter Healthcare Corporation — Class II
20210224
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | Product: Gambro Cartridge Blood Transport System for Hemodialysis Blood Se...
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FDA Device Recall: Hemodialysis Delivery System, Software Version 2.x.
2021-11-17
Class II — If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may su...
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FDA Device Recall: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or
2021-09-08
Class II — Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulat...
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FDA Device Recall: Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET)
2021-09-08
Class II — Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipu...
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FDA Device Recall: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
2021-08-18
Class I — Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
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FDA Device Recall: Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009.
2021-08-18
Class I — System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessi...
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FDA Device Recall: Sharesource Connectivity Platform for Use with the Amia Automated PD System
2021-08-11
Class II — Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultraf...
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FDA Device Recall: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through
2021-07-21
Class II — There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
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FDA Device Recall: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for si
2021-06-02
Class II — There is a potential leak between the venous patient connector and patient's hemodialysis access.
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FDA Device Recall: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement T
2021-03-31
Class II — Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-t...
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FDA Device Recall: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement T
2021-03-31
Class II — Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-t...
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FDA Device Recall: Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G50062
2021-03-31
Class II — Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-t...
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FDA Device Recall: The PrisMax System Version II Hemodialysis Delivery System: Automatic Reposition
2021-03-10
Class II — Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing i...
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FDA Device Recall: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: inte
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, p
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis B
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usa
2021-02-24
Class II — complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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FDA Device Recall: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm,
2021-02-10
Class II — Potential for the battery to lose its ability to be recharged.
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FDA Device Recall: VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of t
2021-01-20
Class II — VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
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FDA Device Recall: MiniCap Extended Life PD Transfer Set
2021-01-13
Class II — Potential for no-flow and leaks under the twist clamp.
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FDA Recall: Baxter Healthcare Corporation — Class I
20201028
Baxter is updating the device IFU for safety communication regarding cleaning practices. | Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
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FDA Recall: Baxter Healthcare Corporation — Class II
20200610
Potential disconnection of tubing set. | Product: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product U
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FDA Recall: Baxter Healthcare Corporation — Class II
20200506
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. | Product: Prismaflex System, Prismaflex Control Uni...
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Produ
2020-12-30
Class II — There is a potential software error during programming.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Produ
2020-12-30
Class II — There is a potential software error during programming.
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FDA Device Recall: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage:
2020-12-30
Class II — There is a potential software error during programming.
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FDA Drug Recall: Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2
2020-11-18
Class II — Presence of particulate matter in solution - black and transparent particles
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
2020-10-28
Class I — Baxter is updating the device IFU for safety communication regarding cleaning practices.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
2020-10-28
Class I — Baxter is updating the device IFU for safety communication regarding cleaning practices.
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FDA Device Recall: Spectrum IQ Infusion System with Dose IQ Safety Software
2020-10-28
Class I — Baxter is updating the device IFU for safety communication regarding cleaning practices.
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FDA Device Recall: Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
2020-07-08
Class II — A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
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FDA Device Recall: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis B
2020-06-10
Class II — Potential disconnection of tubing set.
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FDA Device Recall: Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single us
2020-06-10
Class II — Potential disconnection of tubing set.
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FDA Device Recall: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usa
2020-06-10
Class II — Potential disconnection of tubing set.
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FDA Device Recall: Prismaflex Control Unit
2020-05-27
Class II — Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
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FDA Device Recall: Prismaflex System, Prismaflex Control Unit
2020-05-06
Class II — Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
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FDA Device Recall: Prismaflex System, Prismaflex Control Unit
2020-05-06
Class II — Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
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FDA Device Recall: GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be
2020-04-15
Class II — The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
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FDA Device Recall: GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anast
2020-04-15
Class II — The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
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FDA Device Recall: Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
2020-03-11
Class II — There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
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FDA Device Recall: Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537
2020-01-15
Class II — Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely ...
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FDA Recall: Baxter Healthcare Corporation — Class II
20191113
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporea | Product: Prismaflex Control Unit, software vers...
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FDA Recall: Baxter Healthcare Corporation — Class II
20191113
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporea | Product: Prismaflex Control Unit, software vers...
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FDA Recall: Baxter Healthcare Corporation — Class II
20191113
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporea | Product: Prismaflex Control Unit, software vers...
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FDA Recall: Baxter Healthcare Corporation — Class II
20191106
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a cu | Product: TherMax Blood Warmer Unit
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FDA Recall: Baxter Healthcare Corporation — Class II
20191009
Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette cou | Product: L5C4531 X1 Integrated APD Set with Ca...
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FDA Recall: Baxter Healthcare Corporation — Class II
20190710
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. | Product: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 d...
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FDA Drug Recall: 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Co
2019-11-27
Class II — Lack of Assurance of Sterility: Product has the potential to leak.
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FDA Device Recall: Prismaflex Control Unit, software versions below 7.21
2019-11-13
Class II — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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FDA Device Recall: Prismaflex Control Unit, software versions below 7.21
2019-11-13
Class II — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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FDA Device Recall: Prismaflex Control Unit, software versions below 7.21
2019-11-13
Class II — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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FDA Device Recall: Prismaflex Control Unit, software versions below 7.21
2019-11-13
Class II — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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FDA Device Recall: Prismaflex Control Unit, software versions below 7.21
2019-11-13
Class II — Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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FDA Device Recall: TherMax Blood Warmer Unit
2019-11-06
Class II — TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
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FDA Device Recall: EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product
2019-10-30
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic flui
2019-10-09
Class II — Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile...
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FDA Device Recall: EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHAR
2019-09-04
Class III — EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter He
2019-07-31
Class II — Lack of Assurance of Sterility: Bags have potential to leak.
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FDA Device Recall: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400
2019-07-10
Class II — There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
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FDA Drug Recall: Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for
2019-06-19
Class II — Failed Stability Specifications
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), produc
2019-05-08
Class II — The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. ...
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FDA Device Recall: Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended fo
2019-02-27
Class II — Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
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FDA Device Recall: AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for
2019-02-27
Class II — Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
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FDA Drug Recall: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose,
2019-01-16
Class II — Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
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FDA Recall: Baxter Healthcare Corporation — Class II
20180613
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary | Product: Baxter SIGMA Spectrum Infusion Pump wi...
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FDA Recall: Baxter Healthcare Corporation — Class II
20180530
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibi | Product: Prismaflex 7.20 US, Product Code 95554...
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FDA Recall: Baxter Healthcare Corporation — Class II
20180530
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a | Product: Baxter EXACTAMIX Inlet, Vented, High-V...
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FDA Recall: Baxter Healthcare Corporation — Class II
20180530
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibi | Product: Prismaflex System, Product Code 107493...
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FDA Drug Recall: Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile singl
2018-11-14
Class III — Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
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FDA Device Recall: EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hol
2018-11-07
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to ho
2018-11-07
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to ho
2018-11-07
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to ho
2018-11-07
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to h
2018-11-07
Class II — Potential ability to leak once used for compounding.
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FDA Device Recall: SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
2018-10-24
Class II — If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit e...
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FDA Drug Recall: Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-
2018-10-03
Class III — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Cor
2018-09-26
Class II — cGMP Deviation
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corpo
2018-09-05
Class II — CGMP Deviations
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FDA Device Recall: FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APP
2018-09-05
Class II — Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
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FDA Drug Recall: Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dext
2018-08-15
Class III — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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FDA Drug Recall: Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dex
2018-08-15
Class III — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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FDA Drug Recall: Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dex
2018-08-15
Class III — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusi
2018-06-13
Class II — The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a s...
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusi
2018-06-13
Class II — The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a s...
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FDA Device Recall: Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control
2018-05-30
Class II — Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module e...
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FDA Device Recall: Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta
2018-05-30
Class II — Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiratio...
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FDA Device Recall: Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control
2018-05-30
Class II — Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module e...
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FDA Device Recall: Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control
2018-05-30
Class II — Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module e...
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FDA Device Recall: Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Contro
2018-05-30
Class II — Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module e...
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FDA Device Recall: Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control
2018-05-30
Class II — Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module e...
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FDA Device Recall: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BA
2018-05-16
Class II — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omi...
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FDA Device Recall: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BA
2018-05-16
Class II — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omi...
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FDA Device Recall: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BA
2018-05-16
Class II — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omi...
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FDA Device Recall: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BA
2018-05-16
Class II — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omi...
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FDA Device Recall: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BA
2018-05-16
Class II — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omi...
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FDA Device Recall: Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dia
2018-04-11
Class II — Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, f...
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FDA Device Recall: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 0
2018-03-21
Class II — Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusi...
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FDA Device Recall: Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Co
2018-03-07
Class II — Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
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FDA Drug Recall: Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only
2018-02-07
Class I — Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
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FDA Device Recall: Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are inten
2018-02-07
Class II — A leak may allow for microbial contamination of the sterile fluid path.
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FDA Device Recall: MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 8005
2018-01-31
Class II — Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MA...
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FDA Recall: Baxter Healthcare Corporation — Class II
20170125
Customer complaints received for the presence of leaks | Product: APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patie
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FDA Drug Recall: Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fr
2017-11-01
Class I — Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a...
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FDA Device Recall: HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage:
2017-08-23
Class II — Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set pack...
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FDA Device Recall: HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Us
2017-08-23
Class II — Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packa...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxte
2017-07-19
Class II — Lack of Assurance of Sterility: Customer complaints for leaking bags.
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FDA Drug Recall: 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter H
2017-07-19
Class II — Lack of Assurance of Sterility: Bags have the potential to leak.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter
2017-07-19
Class II — Lack of Assurance of Sterility: Bags have the potential to leak.
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FDA Drug Recall: Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Int
2017-05-24
Class II — Lack of assurance of sterility: customer complaints received for the presence of leaks.
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FDA Drug Recall: Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia
2017-05-24
Class II — Lack of assurance of sterility: customer complaints received for the presence of leaks.
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FDA Device Recall: Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is i
2017-02-01
Class II — Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors co...
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FDA Device Recall: APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in th
2017-01-25
Class II — Customer complaints received for the presence of leaks
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FDA Drug Recall: 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only,
2017-01-18
Class II — Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
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FDA Recall: Baxter Healthcare Corp. — Class II
20161116
Potential presence of particulate matter on the blood side of the dialyzer | Product: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usag
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FDA Recall: Baxter Healthcare Corp — Class II
20160608
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consist | Product: COSEAL Surgical Sealant Kit, 4 mL, Pro...
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FDA Recall: Baxter Healthcare Corp — Class II
20160608
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consist | Product: COSEAL Surgical Sealant Kit, 8 mL, Pro...
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FDA Drug Recall: Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia
2016-12-28
Class II — Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
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FDA Device Recall: V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spec
2016-12-07
Class II — A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear c...
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FDA Device Recall: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1106
2016-11-16
Class II — Potential presence of particulate matter on the blood side of the dialyzer
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FDA Device Recall: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product
2016-08-24
Class II — Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperati...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx On
2016-06-15
Class I — Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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FDA Drug Recall: Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk
2016-06-15
Class I — Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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FDA Device Recall: COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular re
2016-06-08
Class II — Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during u...
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FDA Device Recall: COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re
2016-06-08
Class II — Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during u...
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FDA Drug Recall: Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single D
2016-06-01
Class I — Presence of Particulate Matter: identified as a cloth fiber.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Sing
2016-06-01
Class I — Presence of Particulate Matter: identified as cardboard.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Sing
2016-06-01
Class II — Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
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FDA Drug Recall: CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose wi
2016-06-01
Class I — Presence of Particulate Matter: identified as dried skin.
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FDA Drug Recall: Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Ch
2016-05-18
Class II — Discoloration: presence of atypical yellow discoloration of the solution .
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FDA Device Recall: GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753
2016-05-18
Class II — Instructions for use booklet may puncture the outer Tyvek lid.
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FDA Device Recall: GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752
2016-05-18
Class II — Instructions for use booklet may puncture the outer Tyvek lid.
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FDA Device Recall: GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754
2016-05-18
Class II — Instructions for use booklet may puncture the outer Tyvek lid.
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FDA Device Recall: Automated peritoneal dialysis (APD) cycler
2016-05-04
Class II — Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating th...
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FDA Drug Recall: 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare
2016-03-09
Class II — PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
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FDA Device Recall: Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Mal
2016-01-13
Class II — Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
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FDA Device Recall: Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C.
2016-01-13
Class II — Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
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FDA Recall: Baxter Healthcare Corp. — Class II
20150902
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare prov | Product: MiniCap Extended Life PD Transfer Set ...
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FDA Device Recall: Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated
2015-11-25
Class III — Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with ...
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FDA Device Recall: Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
2015-11-11
Class II — Leakage from the inlet port of the 15L Cycler Drainage Bags.
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FDA Device Recall: ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECT
2015-10-28
Class II — Potential for a leak at the tubing to luer bond.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single D
2015-09-30
Class II — Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
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FDA Device Recall: MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C44
2015-09-02
Class II — Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, ca...
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FDA Device Recall: MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use
2015-09-02
Class II — Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, ca...
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FDA Device Recall: CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. in
2015-09-02
Class II — Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, ca...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx
2015-08-26
Class I — Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Singl
2015-08-26
Class I — Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter
2015-08-19
Class II — Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protector...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured
2015-07-15
Class I — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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FDA Drug Recall: 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter H
2015-07-15
Class I — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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FDA Drug Recall: Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Bax
2015-07-15
Class I — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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FDA Drug Recall: 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter
2015-07-15
Class I — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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FDA Drug Recall: Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 m
2015-06-17
Class II — Subpotent Drug; out of specification results for heparin raw material
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FDA Device Recall: Master Drug Library Software version 8.0, Product Code 35723V080, to be used wit
2015-04-22
Class II — Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integ...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Bax
2015-04-15
Class I — Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack
2015-04-08
Class II — Lack of Assurance of Sterility; increased complaints received for leaks
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FDA Drug Recall: Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose wi
2015-04-08
Class II — Lack of Assurance of Sterility; increased complaints received for leaks
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FDA Drug Recall: 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufa
2015-04-01
Class II — Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx onl
2015-04-01
Class II — Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
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FDA Device Recall: The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice
2015-03-25
Class II — The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2...
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FDA Device Recall: Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid pat
2015-02-11
Class II — Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
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FDA Drug Recall: Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA
2015-02-04
Class II — Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
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FDA Device Recall: Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plasti
2015-02-04
Class II — Potential for failure of the pouch packaging seal at high altitudes.
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FDA Device Recall: HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's
2015-01-14
Class II — There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
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FDA Device Recall: Baxter Amia Automated PD systems are used in the treatment of adult renal failur
2015-01-14
Class II — System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
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FDA Recall: Baxter Healthcare Corp — Class II
20140917
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separatio | Product: ***Baxter***Buretrol Solution Set***10...
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FDA Drug Recall: Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextr
2014-12-24
Class II — Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
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FDA Drug Recall: Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424,
2014-12-17
Class II — Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection prem...
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FDA Drug Recall: Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose contai
2014-12-03
Class II — Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
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FDA Drug Recall: Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL
2014-12-03
Class II — Subpotent Drug: Heparin raw material was found to have low potency
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FDA Device Recall: 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing s
2014-10-22
Class II — The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
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FDA Drug Recall: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose,
2014-10-08
Class I — Presence of Particulate Matter: particulate matter was found during the manufacturing process.
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FDA Drug Recall: DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Ba
2014-10-08
Class II — Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
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FDA Device Recall: SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled ad
2014-10-08
Class II — One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
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FDA Drug Recall: Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L)
2014-10-01
Class II — Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Singl
2014-09-24
Class I — Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
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FDA Drug Recall: Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Contai
2014-09-24
Class I — Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags,
2014-09-24
Class I — Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter H
2014-09-17
Class II — Lack of Assurance of Sterility; complaints of mold in the overpouch
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FDA Device Recall: ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber
2014-09-17
Class II — Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the d...
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FDA Device Recall: ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Dri
2014-09-17
Class II — Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the d...
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FDA Drug Recall: ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag
2014-08-27
Class II — Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron...
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FDA Drug Recall: 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxt
2014-08-27
Class I — Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
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FDA Device Recall: Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corpora
2014-07-23
Class II — Inadequate iodine and packaging related defects.
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FDA Drug Recall: Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg
2014-07-09
Class II — Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
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FDA Device Recall: EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR
2014-07-09
Class II — If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could resul...
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FDA Drug Recall: 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured b
2014-05-07
Class II — Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
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FDA Drug Recall: Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex
2014-05-07
Class I — Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
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FDA Device Recall: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usag
2014-04-30
Class I — Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
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FDA Drug Recall: 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx on
2014-03-26
Class I — Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive...
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FDA Drug Recall: Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CL
2014-03-26
Class I — Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX pl
2014-03-26
Class I — Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesiv...
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FDA Drug Recall: Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextr
2014-03-26
Class I — Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
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FDA Drug Recall: Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000
2014-03-26
Class I — Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
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FDA Drug Recall: 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containe
2014-02-12
Class I — Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
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FDA Recall: Baxter Healthcare Corp. — Class II
20130717
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the e | Product: Two Lead Arthroscopic Irrigation Set, ...
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FDA Recall: Baxter Healthcare Corp. — Class II
20130717
There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investiga | Product: Baxter's elastomeric infusion pumps ar...
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FDA Recall: Baxter Healthcare Corp. — Class II
20130703
leaking pouches | Product: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
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FDA Recall: Baxter Healthcare Corp. — Class II
20130703
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Ba | Product: Brand Name: Intermate Infusion Pump. ...
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FDA Recall: Baxter Healthcare Corp. — Class II
20130515
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its steri | Product: A) Product Code 2N1191: Non-DEHP Y-Typ...
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FDA Drug Recall: 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Dir
2013-12-25
Class II — Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
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FDA Device Recall: Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corpora
2013-12-04
Class II — Incomplete foil seal on one lot of sterile product.
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FDA Device Recall: SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used fo
2013-11-20
Class II — Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-li...
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FDA Device Recall: SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD scree
2013-11-20
Class II — Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic di...
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FDA Device Recall: Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL,
2013-11-06
Class II — The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
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FDA Drug Recall: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose,
2013-08-07
Class II — Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
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FDA Device Recall: Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Container
2013-07-17
Class II — A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromi...
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FDA Device Recall: Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable d
2013-07-17
Class II — There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the inc...
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FDA Device Recall: Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product
2013-07-17
Class II — A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromi...
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FDA Device Recall: Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable d
2013-07-17
Class II — There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the inc...
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FDA Device Recall: Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containe
2013-07-17
Class II — A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromi...
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FDA Drug Recall: Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Contain
2013-07-10
Class II — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactu...
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FDA Drug Recall: Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic
2013-07-10
Class II — Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactur...
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FDA Drug Recall: 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a)
2013-07-10
Class II — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactu...
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FDA Drug Recall: Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter
2013-07-10
Class II — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactu...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0
2013-07-10
Class II — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactu...
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FDA Drug Recall: Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000
2013-07-10
Class II — Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufactu...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, dis
2013-07-03
Class II — Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
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FDA Device Recall: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corpor
2013-07-03
Class II — leaking pouches
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FDA Device Recall: Brand Name: Intermate Infusion Pump. Indicated for the intravenous administra
2013-07-03
Class II — Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and proces...
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FDA Device Recall: Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated
2013-07-03
Class II — Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and proces...
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FDA Device Recall: Brand Name: Intermate Infusion Pump. Indicated for the intravenous administra
2013-07-03
Class II — Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and proces...
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FDA Device Recall: Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter
2013-07-03
Class II — Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
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FDA Device Recall: Brand Name: Multirate Infusor Devices. Indicated for the intravenous administ
2013-07-03
Class II — Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and proces...
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FDA Device Recall: Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:
2013-07-03
Class II — Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
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FDA Device Recall: A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6
2013-05-15
Class II — Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
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FDA Device Recall: A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8
2013-05-15
Class II — Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
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FDA Device Recall: A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, in
2013-05-15
Class II — Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
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FDA Recall: Baxter Healthcare Corp. — Class III
20120905
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be comple | Product: Mini-Infuser Model 150XL Single Speed ...
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FDA Recall: Baxter Healthcare Corp. — Class I
20120815
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an | Product: AUTOMIX High Speed Compounder System, ...
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FDA Device Recall: Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlin
2012-10-17
Class I — Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dos...
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FDA Device Recall: Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burett
2012-10-17
Class I — Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dos...
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FDA Drug Recall: 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxte
2012-10-03
Class II — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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FDA Drug Recall: Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product
2012-10-03
Class II — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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FDA Drug Recall: 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6
2012-10-03
Class II — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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FDA Drug Recall: 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA
2012-10-03
Class II — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, produ
2012-10-03
Class II — Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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FDA Device Recall: Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syri
2012-09-05
Class III — Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not oper...
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FDA Device Recall: Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syring
2012-09-05
Class III — Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not oper...
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FDA Device Recall: AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compou
2012-08-15
Class I — After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the...
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FDA Device Recall: AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automa
2012-08-15
Class I — After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the...
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FDA Device Recall: AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition c
2012-08-15
Class I — After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the...
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FDA Device Recall: AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automat
2012-08-15
Class I — After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the...
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FDA Device Recall: Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Pa
2012-06-20
Class I — Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-...
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fda_adverse
3 records
FDA AE Manufacturer: Baxter Healthcare Corporation
Drug adverse event reporter — Product: METOPROLOL
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FDA AE Manufacturer: Baxter Healthcare Company
Drug adverse event reporter — Product: SODIUM CHLORIDE
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FDA AE Manufacturer: Baxter Healthcare CORP
Drug adverse event reporter — Product: INTRALIPID
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lobbying
8 records
Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by S-3 GROUP — Medical device and technology manufacturer
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Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by PORTERFIELD, FETTIG & SEARS, LLC — Manufacturer of medical devices and other health care technology.
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Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by CAPITOL COUNSEL LLC — Maker of healthcare, renal, and hospital products.
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Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by BAKER & HOSTETLER LLP — Medical device and technology manufacturer.
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Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by S-3 GROUP — Medical device and technology manufacturer
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Lobbying Client: BAXTER HEALTHCARE CORPORATION
Lobbied by S-3 GROUP — Medical device and technology manufacturer
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nppes
1 records
ny_corps
1 records
NY Corp: BAXTER HEALTHCARE CORPORATION
1966-10-31
FOREIGN BUSINESS CORPORATION | County: Richmond | Jurisdiction: Delaware
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OSHA
2 records
OSHA Inspection (Referral) - Baxter Healthcare Corporation
2015-06-04
OSHA inspection at Baxter Healthcare Corporation, MARION, NC. NAICS: 325412. SIC: 2834
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OSHA Inspection (Accident) - Baxter Healthcare Corp
1994-09-16
OSHA inspection at Baxter Healthcare Corp, CAROLINA, PR. NAICS: 000000. SIC: 2834
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