Recall Z-0490-2015— Gambro Renal Products Inc
Class II · Terminated
Class II FDA medical device recall by Gambro Renal Products Inc, initiated 2014-11-05, terminated 2015-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Gambro Renal Products Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-05
- Terminated
- 2015-05-20
- Firm location
- Opelika, AL, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.