Device recall
Z-0490-2015: Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and…
FDA device recall · Class II · Gambro Renal Products Inc
Key facts
| Recall number (Z-number) | Z-0490-2015 |
|---|---|
| Recall event | 69786 |
| 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. |
| Product code | KDI |
| Recalling firm | Gambro Renal Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2015 |
| FEI number | 3006552611 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database