D-1140-2023 Class II Terminated
FDA drug recall D-1140-2023 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: a) 44,520; b) 60,762; c) 483,912.
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
- a) 44,520; b) 60,762; c) 483,912
Product description
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL 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
a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1140-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026