FDARecalled Sep 6, 2023 · #D-1140-2023
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 Contai...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Baxter Healthcare Corporation
- Model numbers
- Y406277, 408790, Y420075
- UPCs
- —