Recall: D-0652-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-26Initiated

OngoingStatus

B BRAUN MEDICAL INCFirm

Product

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

Reason

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.