Drug product
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
D-0543-2023
Product summary
- Event
- Event 91883
- Status
- Completed
- Classification
- Class II
- Quantity
- 9,788 bags
- Official record key
drug-enforcement:D-0543-2023
Official wording
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Code information: Lot Y405201, Exp 31-Oct-2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility