D-0498-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2026
- Initiation Date
- April 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,540 bags
Product Description
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Reason for Recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Distribution Pattern
US Nationwide.
Code Information
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.