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

Recall Number: D-0652-2025

Firm: B BRAUN MEDICAL INC

Classification: Class II

Status: Ongoing

Report Date: 20250924

Initiation Date: 20250826

Termination Date:

Reason for Recall

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

Product Description

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