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Recall Observatory FDA recall evidence

Drug product

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

D-0498-2026

April 02, 2026

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 98693
Status
Ongoing
Classification
Class II
Quantity
54,540 bags
Official record key
drug-enforcement:D-0498-2026

Official wording

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

Code information: Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility