B Braun Medical Inc: Sterile Water For Injection Usp
B. Braun Medical Inc. is recalling 3000 mL bags of Sterile Water for Injection USP (a prescription pharmacy bulk package) distributed nationwide because the product may leak from the diaphragm port after the protective foil is removed, which could compromise sterility. This recall affects healthcare facilities and pharmacies that received this product across all U.S. states.
- Recalling firm
- B BRAUN MEDICAL INC
- Product
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- 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/f46549d0-74d4-4bab-aebd-95830b670040