Drug recall D-0542-2023
Product
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.
Reason for recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lots and codes
Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- a) 95,448 bags; b) 174,522 bags
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2023
Related products
- DIANEAL Low Calcium with Dextrose – drug information
- NDC 0941-0415 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0413 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0409 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0429 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0411 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0457 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0426 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0487 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0490 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0459 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0484 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0424 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0433 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0430 DIANEAL Low Calcium with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC
- NDC 0941-0427 DIANEAL PD-2 with Dextrose · Dextrose Monohydrate 2.5 g/100mL; Sodium Chloride 538… · Vantive US Healthcare LLC