FDAHealthJune 17, 2024
Baxter Healthcare Corporation — 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 Co
⚠️ Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 17, 2024
US Nationwide, Canada
What's affected?
- 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
- Lot code
- R24B25FA
Additional details
Lot R24B25FA; Exp. 2/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,874 bags.
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