B Braun Medical Inc: Sterile Water For Injection Usp
Summary B. Braun Medical Inc. is recalling 3000 mL bags of Sterile Water for Injection USP nationwide because the product may leak from the diaphragm port after the foil covering is removed, which could compromise its sterility. This is a pharmacy bulk package product used in healthcare settings across all U.S. states. The company cannot guarantee the sterility of affected batches due to this potential leakage issue.
- 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/3d51b0de-92d3-4a37-b369-0f6974f3718d