Class II
Ongoing
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Company
- B Braun Medical Inc
- Recall Initiated
- August 26, 2025
- Posted
- September 24, 2025
- Recall Number
- D-0652-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 26,316 3000 mL bags
- Firm Location
- Allentown, PA, United States
Reason for Recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Distribution
U.S. Nationwide
Lot / Code Info
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
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