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
Product summary
- 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
Lack of Assurance of Sterility