FDA Recall D-0652-2025
B BRAUN MEDICAL INC · Allentown, PA
Class II Ongoing 261 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall record
- Recall number
D-0652-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-08-26
- Classified by FDA Center
- 2025-09-16
- FDA published
- 2025-09-24
- Recalling firm
- B BRAUN MEDICAL INC
- Firm location
- Allentown, PA
Drug identification
- Brand name(s)
- STERILE WATER
- Generic name(s)
- WATER
- Manufacturer(s)
- B. Braun Medical Inc.
- NDC(s)
0264-7385- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.