D-0542-2023 Class II
FDA drug recall D-0542-2023 was initiated by Baxter Healthcare Corporation on March 15, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Affected quantity: a) 95,448 bags; b) 174,522 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- March 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 95,448 bags; b) 174,522 bags
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024