co_sos
1 records
CO Business: B. BRAUN MEDICAL INC.
1997-12-29
FPC | Status: Good Standing | Bethlehem, PA
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fda
342 records
FDA Recall: B BRAUN MEDICAL INC — Class II
20260429
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. | Product: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., B...
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FDA Device Recall: Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7
2026-03-11
Class II — The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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FDA Device Recall: Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal
2026-03-11
Class II — The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Blood Administration Set utilized in gravity...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Blood Administration Set utilized in gravity...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: SafeDAY set utilized in gravity IV administr...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Anesthesia IV Set utilized in gravity IV adm...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Infusomat utilized in gravity IV administrat...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Extension Set utilized in gravity IV adminis...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Extension Set utilized in gravity IV adminis...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: IV Administration Set utilized in gravity IV...
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FDA Recall: B Braun Medical Inc — Class II
20251203
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Product: Extension Set utilized in gravity IV adminis...
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FDA Device Recall: Blood Administration Set utilized in gravity IV administration sets and pump adm
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Blood Administration Set utilized in gravity IV administration sets and pump adm
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: SafeDAY set utilized in gravity IV administration sets and pump administration s
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Anesthesia IV Set utilized in gravity IV administration sets and pump administra
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Infusomat utilized in gravity IV administration sets and pump administration set
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Outlook set utilized in gravity IV administration sets and pump administration s
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Blood Administration Set utilized in gravity IV administration sets and pump adm
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Vista set utilized in gravity IV administration sets and pump administration set
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: ADDitIV utilized in gravity IV administration sets and pump administration sets
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Burette Set utilized in gravity IV administration sets and pump administration s
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Anesthesia IV Set utilized in gravity IV administration sets and pump administra
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: ADDitIV utilized in gravity IV administration sets and pump administration sets
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Caresite utilized in gravity IV administration sets and pump administration sets
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Caresite utilized in gravity IV administration sets and pump administration sets
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Blood Administration Set utilized in gravity IV administration sets and pump adm
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Anesthesia IV Set utilized in gravity IV administration sets and pump administra
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Anesthesia IV Set utilized in gravity IV administration sets and pump administra
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: SAFELINE set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Outlook set utilized in gravity IV administration sets and pump administration s
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Extension Set utilized in gravity IV administration sets and pump administration
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: Anesthesia IV Set utilized in gravity IV administration sets and pump administra
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: ADDitIV utilized in gravity IV administration sets and pump administration sets
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
View Source
FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: IV Administration Set utilized in gravity IV administration sets and pump admini
2025-12-03
Class II — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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FDA Device Recall: Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR
2025-10-29
Class I — The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
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FDA Device Recall: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in.
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Device Recall: Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions:
2025-10-15
Class II — Potential for the lid of the catheter connector to be in the incorrect position.
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FDA Drug Recall: 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, R
2025-09-24
Class II — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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FDA Drug Recall: STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethleh
2025-09-24
Class II — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical
2025-09-10
Class I — Presence of Particulate Matter.
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FDA Drug Recall: Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical,
2025-09-10
Class I — Presence of Particulate Matter
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Ste
2025-08-20
Class II — Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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FDA Drug Recall: Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Steril
2025-08-20
Class II — Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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FDA Device Recall: Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use w
2025-08-13
Class I — Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers
2025-07-02
Class II — Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
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FDA Drug Recall: 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Pl
2025-04-16
Class II — Presence of Particulate Matter
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FDA Recall: B Braun Medical Inc — Class II
20240925
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for | Product: SL BLOODLINE FOR FMC 2008 SERIES-Tubin...
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FDA Recall: B Braun Medical Inc — Class II
20240731
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to | Product: Brand Name: Perfusor Space Product Na...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240724
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV contain | Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 I...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240724
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV contain | Product: Infusomat UNIV. 15 DROP PUMP SET, 3 CA...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240724
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV contain | Product: Infusomat 60DROP METRISET PUMP SET, 3...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240724
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV contain | Product: Infusomat UNIV. 60 DROP PUMP SET, 2 CA...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240724
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV contain | Product: Infusomat UNIV. 15 DR PUMP SET, 1.2FI...
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FDA Recall: B. Braun Medical, Inc. — Class II
20240228
Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interfac | Product: Epidural tray. PERIFIX 17 Ga. x 3-1/2...
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FDA Device Recall: SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a p
2024-09-25
Class II — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback pro...
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FDA Device Recall: STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a pa
2024-09-25
Class II — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback pr...
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FDA Device Recall: STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a pa
2024-09-25
Class II — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback pr...
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FDA Device Recall: STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between
2024-09-25
Class II — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback pr...
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FDA Device Recall: STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haem
2024-09-25
Class II — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback pr...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun M
2024-08-28
Class I — Presence of Particulate Matter
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FDA Device Recall: Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless
2024-07-31
Class II — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may r...
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FDA Device Recall: Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catal
2024-07-31
Class II — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may r...
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FDA Device Recall: Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog
2024-07-31
Class II — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may r...
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FDA Device Recall: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infus
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powe
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powere
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-pow
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-po
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-pow
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusio
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powe
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-pow
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-pow
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powere
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-power
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered i
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pu
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powe
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-po
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-p
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-power
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered inf
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-po
2024-07-24
Class II — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulti...
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FDA Device Recall: Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
2024-06-19
Class II — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
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FDA Device Recall: Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
2024-06-19
Class II — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
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FDA Drug Recall: Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medic
2024-04-10
Class II — Lack of assurance of sterility: bags have the potential to leak..
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FDA Drug Recall: Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250
2024-03-20
Class II — Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
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FDA Device Recall: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock L
2024-02-28
Class II — Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
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FDA Device Recall: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Spri
2024-02-28
Class II — Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
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FDA Device Recall: Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump
2023-12-13
Class I — In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and ...
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FDA Device Recall: TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. I
2023-11-15
Class II — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare wo...
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FDA Device Recall: THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use adm
2023-11-15
Class II — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare wo...
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FDA Device Recall: 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management
2023-11-15
Class II — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare wo...
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FDA Device Recall: 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
2023-11-01
Class I — Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requi...
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FDA Device Recall: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Inf
2023-11-01
Class I — Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requi...
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FDA Device Recall: B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver
2023-10-04
Class II — The sterile blister packaging may be damaged, and sterility may be compromised
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FDA Device Recall: B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inj
2023-10-04
Class II — The sterile blister packaging may be damaged, and sterility may be compromised
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FDA Device Recall: Perifix¿ / Epidural anesthesia set, medicated
2023-09-27
Class II — Product may be mislabeled with an incorrect lid stock label.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Br
2023-08-16
Class III — Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Br
2023-07-19
Class II — Lack of assurance of sterility: bags have the potential to leak.
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FDA Device Recall: Design Options¿ / Epidural anesthesia kit (10 count carton)
2023-07-05
Class II — Kits were assembled with the incorrect Filter Straw.
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FDA Drug Recall: Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextros
2023-05-24
Class II — Subpotent: Low anti-factor IIa Potency.
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FDA Drug Recall: Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextros
2023-03-15
Class II — Subpotent Drug: low Anti-Factor IIa potency.
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Br
2023-03-01
Class II — Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may ca...
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FDA Drug Recall: 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. B
2023-03-01
Class II — Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may ca...
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FDA Recall: B Braun Medical Inc — Class II
20221012
Potential for leakage at the catheter hub. | Product: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to prov
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FDA Recall: B Braun Medical Inc — Class II
20220420
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could | Product: Conductivity Sensors utilized on Dialo...
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FDA Recall: B. Braun Medical, Inc. — Class II
20220316
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decrea | Product: Dispensing Pins for Air Inlet Filter, ...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 026
2022-12-14
Class II — Lack of sterility assurance: Bags have the potential to leak.
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FDA Device Recall: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-n
2022-10-12
Class II — Potential for leakage at the catheter hub.
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FDA Device Recall: Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Condu
2022-04-20
Class II — Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or...
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FDA Device Recall: Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Condu
2022-04-20
Class II — Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or...
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FDA Drug Recall: 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Me
2022-03-23
Class II — Lack of sterility assurance: leaking bags
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FDA Device Recall: Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispen
2022-03-16
Class II — This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered t...
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FDA Recall: B. Braun Medical, Inc. — Class II
20210804
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to fo | Product: Infusomat Space Volumetric Pump Admini...
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FDA Device Recall: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety I
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the O
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administrat
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Sa
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Saf
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with th
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, f
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Inf
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the O
2021-10-06
Class II — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
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FDA Device Recall: Infusomat Space Volumetric Pump Administration Set, Product Code 490100
2021-08-04
Class II — There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roll...
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FDA Recall: B Braun Medical, Inc. — Class II
20201230
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3 | Product: APEX Compounding System Control Panel ...
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FDA Device Recall: APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 -
2020-12-30
Class II — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredie...
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FDA Device Recall: APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 -
2020-12-30
Class II — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredie...
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FDA Device Recall: APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 -
2020-12-30
Class II — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredie...
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FDA Drug Recall: Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex
2020-05-06
Class I — Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
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FDA Device Recall: Y-Type Blood Set, Catalog Number 490425
2020-02-12
Class II — Potential for leakage at the joint between the blood filters and tubing
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FDA Device Recall: Y-Type Blood Set, Catalog Number 490293
2020-02-12
Class II — Potential for leakage at the joint between the blood filters and tubing
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FDA Device Recall: Y-Type Blood Set, Catalog Number 490530
2020-02-12
Class II — Potential for leakage at the joint between the blood filters and tubing
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FDA Device Recall: Y-Type Blood Set, Catalog Number 490314
2020-02-12
Class II — Potential for leakage at the joint between the blood filters and tubing
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FDA Device Recall: Safeline Y-Type Blood Set, Catalog Number V2500
2020-02-12
Class II — Potential for leakage at the joint between the blood filters and tubing
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FDA Recall: B. Braun Medical, Inc. — Class II
20190911
The filter capacity is not achieved due to damage of the filter membrane. | Product: CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
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FDA Recall: B. Braun Medical, Inc. — Class II
20190911
The filter capacity is not achieved due to damage of the filter membrane. | Product: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
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FDA Device Recall: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Num
2019-10-02
Class I — Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
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FDA Device Recall: CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Device Recall: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Device Recall: CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Device Recall: CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Device Recall: CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Device Recall: CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
2019-09-11
Class II — The filter capacity is not achieved due to damage of the filter membrane.
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FDA Drug Recall: Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose
2019-06-19
Class II — Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specification...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE17TKFSDTD EPID TRAY W/17GA FIXED WIN...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CNB200TKU NON-STIM CATH FULL KIT, Mate...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CNBFX350O CONTIPLEX CONT NERVE BLOCK, ...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE17TKPS CONTINUOUS EPIDURAL ANES TRAY...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE17TKCD CONT EPIDURAL ANESTHESIA KIT,...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: EPID PAED FULL KIT 24GA CT NG CATH LF,...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB S...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE17TKFCS CONT EPID TRAY W/17G TUOHY-L...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE18TKCD CONT EPIDURAL TRAY, Material ...
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FDA Recall: B. Braun Medical, Inc. — Class II
20181010
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has be | Product: CE18TBLS CONT EPIDURAL TRAY, Material ...
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FDA Device Recall: CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device u
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection devi
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used b
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used b
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device u
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device use
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used b
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection devic
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by p
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device u
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by ph
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used by
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used b
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 5
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection devi
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device use
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device use
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device u
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by ph
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection devic
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection devic
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection de
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by ph
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection d
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device use
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection dev
2018-10-10
Class II — The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
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FDA Device Recall: 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Numb
2018-07-11
Class II — There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potenti...
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FDA Device Recall: Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product
2018-07-04
Class II — There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
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FDA Drug Recall: 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC),
2018-03-07
Class II — Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container c...
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FDA Device Recall: Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local ane
2018-02-21
Class II — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter ...
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FDA Device Recall: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 33
2018-02-21
Class II — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter w...
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FDA Device Recall: Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024
2018-02-21
Class II — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter ...
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FDA Device Recall: PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthe
2018-02-21
Class II — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter ...
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FDA Device Recall: Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252.
2018-02-21
Class II — B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter w...
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FDA Drug Recall: 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B.
2017-12-27
Class II — Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
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FDA Device Recall: CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (
2017-05-31
Class II — B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
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FDA Recall: B. Braun Medical, Inc. — Class II
20160608
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the bl | Product: Non-Vented Dispensing Pin with One-Way...
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FDA Recall: B Braun Medical Inc — Class I
20160511
Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Product: Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169
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FDA Device Recall: Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start pr
2016-12-07
Class II — Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
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FDA Drug Recall: 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Me
2016-10-19
Class I — Non-Sterility: fungal contamination due to leaking containers.
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FDA Device Recall: Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Pr
2016-06-08
Class II — BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit lab...
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FDA Device Recall: WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery t
2016-06-01
Class II — Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
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FDA Device Recall: Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200
2016-05-11
Class I — Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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FDA Device Recall: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Cod
2016-05-11
Class I — Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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FDA Device Recall: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dial
2016-05-11
Class I — Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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FDA Device Recall: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code #
2016-05-11
Class I — Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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FDA Device Recall: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Di
2016-05-11
Class I — Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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FDA Device Recall: Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anestheti
2015-10-28
Class II — Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
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FDA Device Recall: CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Ne
2015-05-13
Class II — There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A co...
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FDA Recall: B. Braun Medical, Inc. — Class II
20140212
Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time | Product: B. Braun AccuFlo Elastomeric Infusion ...
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FDA Device Recall: STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 in
2014-07-16
Class II — Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open positi...
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FDA Device Recall: Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal i
2014-06-04
Class II — B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
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FDA Drug Recall: Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container,
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL C
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Con
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Ste
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Cont
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Co
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bul
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 100
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Cata
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Drug Recall: Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe
2014-05-07
Class I — Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
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FDA Device Recall: SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.
2014-02-26
Class II — Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to prov...
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FDA Drug Recall: Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery S
2014-02-12
Class I — Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
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FDA Device Recall: B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for
2014-02-12
Class II — Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion...
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FDA Drug Recall: 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun
2014-01-22
Class II — Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
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FDA Device Recall: B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 42516
2014-01-01
Class II — One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
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FDA Recall: B. Braun Medical, Inc. — Class II
20131204
Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensi | Product: 20mm addEASE(TM) Binary Connector with...
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FDA Recall: B. Braun Medical, Inc. — Class II
20130918
Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined t | Product: Outlook Safety Infusion System Burette...
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FDA Device Recall: 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Contain
2013-12-04
Class II — Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has bee...
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FDA Device Recall: Outlook Safety Infusion System Burette Set. For intravenous fluid administrat
2013-09-18
Class II — Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection site...
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FDA Device Recall: Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV S
2013-09-18
Class II — This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the C...
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FDA Device Recall: Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV S
2013-09-18
Class II — B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This coul...
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FDA Device Recall: Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to fi
2013-05-08
Class II — There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficien...
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FDA Device Recall: Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. Th
2013-01-09
Class II — Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
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fda_adverse
1 records
FDA AE Manufacturer: B. Braun Medical Inc.
Drug adverse event reporter — Product: SODIUM CHLORIDE
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lobbying
4 records
Lobbying Client: B. BRAUN MEDICAL INC.
Lobbied by POLSINELLI PC — Medical device manufacturer
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ny_corps
1 records
NY Corp: B. BRAUN MEDICAL INC.
1995-03-20
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Texas
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