Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II
Recalled May 3, 2023 · FDA recall D-0542-2023 · Baxter Healthcare
Hazard
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. · FDA Class II
Units
a) 95,448 bags; b) 174,522 bags
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product
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.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →