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Recall Observatory FDA recall evidence

Drug 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.

D-0653-2025

August 26, 2025

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 97477
Status
Ongoing
Classification
Class II
Quantity
16,228 3000 mL bags
Official record key
drug-enforcement:D-0653-2025

Official wording

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

Code information: Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility