Baxter Healthcare Corporation recalls DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Containe
Recalled September 6, 2023 · FDA recall D-1140-2023 · Baxter Healthcare
Hazard
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. · FDA Class II
Units
a) 44,520; b) 60,762; c) 483,912
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) 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.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →