FDA-Device2019-07-10Class II
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
Hazard
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Sold states
US Nationwide Distribution and Internationally to: Canada and Bermuda.
Affected count
1249272 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1908-2019Don't want to check this manually?
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