FDA-Drug2023-05-03Class II
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
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
9,788 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2023Don't want to check this manually?
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