Recall D-0653-2025

US Class II Ongoing · initiated 2025-08-26

Recalling firm

B BRAUN MEDICAL INC, PA

Product

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.

Reason for recall

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

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