Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

Reason: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.

Code information: Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001

Distribution pattern: Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.