D-0587-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,874 bags
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Distribution Pattern
US Nationwide, Canada
Code Information
Lot R24B25FA; Exp. 2/28/2026