Recalls / Class II
Class IID-0587-2024
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
- Brand name
- Dianeal Low Calcium With Dextrose
- Generic name
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424 +5 more
- FDA application
- NDA017512
- Affected lot / code info
- Lot R24B25FA; Exp. 2/28/2026
Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Vantive US Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 6,874 bags
- Distribution pattern
- US Nationwide, Canada
Timeline
- Recall initiated
- 2024-06-17
- FDA classified
- 2024-07-06
- Posted by FDA
- 2024-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0587-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.