FDAOctober 12, 2016device
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential presence of particulate matter on the blood side of the dialyzer
What to do
FDA enforcement status: Terminated
Brands named
baxter healthcarebaxter
Recall history
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