Drug product
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
D-1141-2023
Product summary
- Event
- Event 92931
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,112 bags
- Official record key
drug-enforcement:D-1141-2023
Official wording
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Code information: Lot Y406734, Exp 31-Oct-2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility