Home / Recalls / Medical Devices
Baxter Healthcare Corporation recalls REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment o
Recalled July 10, 2019 · FDA recall Z-1908-2019 · Baxter Healthcare
Hazard
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. · FDA Class II
Units
1249272 units
Sold at
US Nationwide Distribution and Internationally to: Canada and Bermuda.
Description
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Product
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →