0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

Recall Number: D-0653-2025

Firm: B BRAUN MEDICAL INC

Classification: Class II

Status: Ongoing

Report Date: 20250924

Initiation Date: 20250826

Termination Date:

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

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.