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Baxter Healthcare Corp. recalls GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Ma
Recalled November 16, 2016 · FDA recall Z-0370-2017 · Baxter Healthcare
Hazard
Potential presence of particulate matter on the blood side of the dialyzer · FDA Class II
Units
22,656 units
Sold at
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Description
Potential presence of particulate matter on the blood side of the dialyzer
Product
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.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →