Z-0489-2015 Class II Terminated
FDA device recall Z-0489-2015 was initiated by Gambro Renal Products Inc on November 5, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 20, 2015). Affected quantity: 20 million dialyzers.
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2014
- Initiation Date
- November 5, 2014
- Termination Date
- May 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 million dialyzers
Product Description
Polyflux Revaclear Dialyzer, Model Number 110633. 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.
Distribution Pattern
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Code Information
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001