B Braun Medical Inc: Sterile Water For Injection Usp
Recall Summary B. Braun Medical Inc. is recalling 3000 mL bags of Sterile Water for Injection USP (a pharmacy bulk package medication) distributed nationwide because the product may leak from the diaphragm port after the foil is removed, which could compromise sterility. This recall affects healthcare facilities and pharmacies across all 50 states that received this product.
- 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.
- 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/4123c2c0-f12c-4174-a3e7-f27a111cdce6