FDA-Drug2023-09-06Class II
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.
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) 44,520; b) 60,762; c) 483,912
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1140-2023Don't want to check this manually?
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