Recall D-0497-2026

US Class II Ongoing · initiated 2026-04-02

Recalling firm

B BRAUN MEDICAL INC, PA

Product

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Reason for recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

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