Drug product
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
D-0542-2023
Product summary
- Event
- Event 91883
- Status
- Completed
- Classification
- Class II
- Quantity
- a) 95,448 bags; b) 174,522 bags
- Official record key
drug-enforcement:D-0542-2023
Official wording
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Code information: Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility