Recall Z-0490-2015 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products Inc
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.
| Date | Dec 1, 2014 (initiated Nov 5, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers. |
| Quantity | 20 million dialyzers |
| Distribution | Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.