D-1141-2023 Class II Terminated
FDA drug recall D-1141-2023 was initiated by Baxter Healthcare Corporation on Aug 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 Jul 16, 2024). Affected quantity: 22,112 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 6, 2023
- Initiation Date
- Aug 11, 2023
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1141-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026