D-0542-2023 Class II
FDA drug recall D-0542-2023 was initiated by Baxter Healthcare Corporation on Mar 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
- Mar 15, 2023
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0542-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026