Recalls / Class II
Class IID-0652-2025
Product
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Brand name
- Sterile Water
- Generic name
- Water
- Active ingredient
- Water
- Route
- Intravenous
- NDC
- 0264-7385
- FDA application
- NDA019633
- Affected lot / code info
- Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
Why it was recalled
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recalling firm
- Firm
- B BRAUN MEDICAL INC
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 861 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9577
Distribution
- Quantity
- 26,316 3000 mL bags
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-08-26
- FDA classified
- 2025-09-16
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0652-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.