Drug 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.
D-0351-2019
Product summary
- Event
- Event 81881
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,370 bags
- Official record key
drug-enforcement:D-0351-2019
Official wording
Reason: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Code information: Lot #: Y281477, Expiry: 02/2020
Distribution pattern: Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility