FDA-Device2016-11-16Class II
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.
Baxter Healthcare Corp.
Hazard
Potential presence of particulate matter on the blood side of the dialyzer
Sold states
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Affected count
22,656 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0370-2017Don't want to check this manually?
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