FDAHealthApril 2, 2026
B BRAUN MEDICAL INC — LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
⚠️ Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2026
US Nationwide.
What's affected?
- Product
- LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- Lot code
- J5E234
Additional details
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 54,540 bags.
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