FDA-Drug2023-05-03Class II
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.
Baxter Healthcare Corporation
Hazard
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Sold states
Nationwide in the USA
Affected count
a) 95,448 bags; b) 174,522 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2023Don't want to check this manually?
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