Recalls / Class II
Class IID-0543-2023
Product
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
- 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 Y405201, Exp 31-Oct-2024
Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer 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
- 9,788 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-15
- FDA classified
- 2023-04-24
- Posted by FDA
- 2023-05-03
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0543-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.