Reported Jul 10, 2019 · Terminated
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of…
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 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
- Lot codes and dates
- UDI 07332414123055 Lot Numbers
C419105401C419105501C419105601C419105701C419105801C419105901C419106001C419106101C419106201C419106301C419106401C419106501C419106601C419106701C419106801C419106901C419107001C419107101C419107201C419107301C419107401C419107501C419107601C419107701C419107801C419107901C419108001C419108101C419108201C419108301C419108401C419108501C419108601C419108701C419108801C419108901C419109001C419109101C419109201C419109301C419109401C419109501C419109601C419109801C419110001C419110101C419110201C419110301C419110401C419110501C419110601C419110701C419110801C419111001C419111101C419111301C419111501C419111601C419111701
- UDI 07332414123055 Lot Numbers
- Amount recalled
- 1249272 units
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
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
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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