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Gambro Renal Products, Incorporated recalls Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment
Recalled May 28, 2014 · FDA recall Z-1643-2014 · Gambro Renal Products, Incorporated
Hazard
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. · FDA Class II
Units
2,461,824 units total
Sold at
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Description
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Product
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Manufacturer(s)
Gambro Renal Products, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →