B Braun Medical Inc: 0.9 % Sodium Chloride Irrigation, Usp
Recall Summary B. Braun Medical Inc. is recalling 3000 mL bags of 0.9% Sodium Chloride Irrigation solution distributed nationwide because the product may leak from the diaphragm port after the protective foil is removed, and there is no assurance the solution remains sterile. This prescription irrigation solution was distributed across all U.S. states and the District of Columbia.
- Recalling firm
- B BRAUN MEDICAL INC
- Product
- 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3955028e-b402-436d-b099-78c6e9fe78fa