FDA-Drug2023-09-06Class II
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
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
22,112 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1141-2023Don't want to check this manually?
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