B. Braun Medical, Inc.
97 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for B. Braun Medical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-10-04FDA-DeviceClass IIB. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
The sterile blister packaging may be damaged, and sterility may be compromised
- 2023-09-27FDA-DeviceClass IIPerifix¿ / Epidural anesthesia set, medicated
Product may be mislabeled with an incorrect lid stock label.
- 2023-08-16FDA-DrugClass III0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- 2023-07-19FDA-DrugClass II0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Lack of assurance of sterility: bags have the potential to leak.
- 2023-07-05FDA-DeviceClass IIDesign Options¿ / Epidural anesthesia kit (10 count carton)
Kits were assembled with the incorrect Filter Straw.
- 2023-07-05FDA-DeviceClass IIPerifix¿ / Epidural anesthesia kit (10 count carton)
Kits were assembled with the incorrect Filter Straw.
- 2023-05-24FDA-DrugClass IIHeparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Subpotent: Low anti-factor IIa Potency.
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