D-0652-2025 Class II Ongoing
FDA drug recall D-0652-2025 was initiated by B BRAUN MEDICAL INC on August 26, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. The recall status is ongoing. Affected quantity: 26,316 3000 mL bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2025
- Initiation Date
- August 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,316 3000 mL bags
Product Description
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.
Distribution Pattern
U.S. Nationwide
Code Information
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027