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 initiated: 20250826
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated