Reported Dec 28, 2022 · Ongoing
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
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?
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Lot codes and dates
- a
- UDI-DI07332414124076
- Product Code114746L; All lot numbers from C421221401-C422228501. b
- UDI-DI07332414126209
- Product Code
114746MAll lot numbers from C422218601-C422219901
- Amount recalled
- 6,338,280 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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