D-0587-2024 Class II Ongoing
FDA drug recall D-0587-2024 was initiated by Baxter Healthcare Corporation on Jun 17, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. The recall status is ongoing. Affected quantity: 6,874 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 17, 2024
- Initiation Date
- Jun 17, 2024
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0587-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026