Reported Dec 28, 2022 · Ongoing
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal…
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 Code114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis
- Lot codes and dates
- Not distributed in the USA
- Product Code114749M
- Lot Numbers
C422202401C422202501C422202601C422202701C422202801C422202901C422203001C422203101C422203201C422203301C422203401C422203501C422203601C422203701C422203801C422203901C422204001C422204101C422204201C422204301C422204401C422204501C422204701
- Amount recalled
- 449,544 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.
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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