Reported Dec 28, 2022 · Ongoing
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat 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 Dialyzer
- Product Code114746L. Used to treat chronic and acute renal failure by hemodialysis
- Lot codes and dates
- UDI-DI07332414124076
- Product Code114746L
- Lot Numbers
180 of 180 codes
C421222601C421222701C421222801C421222901C421223001C421223101C421223201C421223301C421223401C421223501C421223601C421223701C421223801C421223901C421224001C421224101C421224201C421224301C421224401C421224601C421224701C421224801C421224901C421225001C421225101C421225201C421225301C421225401C421225501C421225601C421225701C421225801C421225901C421226001C421226101C421226201C421226301C421226401C421226501C421226601C421226701C421226801C421226901C421227001C421227101C421227201C421227301C421227401C421227501C421227601C421227701C421227801C421227901C421228001C421228101C421228201C421228301C421228401C421228501C421228601
- Amount recalled
- 3,610,944 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
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
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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