Reported Sep 6, 2023 · Terminated
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
L5B4825 | 2000 mL AMBU-FLEX II Container bag, , NDC 0941-0409-06 |
L5B4826 | 5000 mL AMBU-FLEX II Container bag, , NDC 0941-0409-07; and |
L5B9770 | 6000 mL AMBU-FLEX II Container bag, , NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. 2 Lot 408790, Exp 30-Nov-2024 and 3 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 - Amount recalled
- a) 44,520; b) 60,762; c) 483,912
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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