D-1141-2023 Class II Terminated
FDA drug recall D-1141-2023 was initiated by Baxter Healthcare Corporation on August 11, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. The recall status is terminated (terminated July 16, 2024). Affected quantity: 22,112 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 11, 2023
- Termination Date
- July 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,112 bags
Product Description
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
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 Y406734, Exp 31-Oct-2024