FDA-Device2014-05-28Class II
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Gambro Renal Products, Incorporated
Hazard
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Sold states
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Affected count
2,461,824 units total
Manufactured in
14143 Denver West Pkwy, N/A, Lakewood, CO, United States
Products
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1643-2014Don't want to check this manually?
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