Recalls / Class II
Class IID-1140-2023
Product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
- 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
- a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025
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
- a) 44,520; b) 60,762; c) 483,912
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-11
- FDA classified
- 2023-08-29
- Posted by FDA
- 2023-09-06
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1140-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.