Recall D-0491-2025

US Class II Ongoing · initiated 2025-06-16

Recalling firm

B BRAUN MEDICAL INC, PA

Product

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

Reason for recall

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

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