Drug product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
D-0587-2024
Product summary
- Event
- Event 94846
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,874 bags
- Official record key
drug-enforcement:D-0587-2024
Official wording
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Code information: Lot R24B25FA; Exp. 2/28/2026
Distribution pattern: US Nationwide, Canada
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility