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
Product summary
- 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
Lack of Assurance of Sterility