Drug recall D-0351-2019
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Reason for recall
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Lots and codes
Lot #: Y281477, Expiry: 02/2020
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 29,370 bags
- Distribution
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 2, 2019
- Terminated
- April 29, 2020
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