Device recall
Z-1644-2014: Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal…
FDA device recall · Class II · Gambro Renal Products, Incorporated
Key facts
| Recall number (Z-number) | Z-1644-2014 |
|---|---|
| Recall event | 67996 |
| Product | Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. |
| Product code | KDI |
| Recalling firm | Gambro Renal Products, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2015 |
| 510(k) numbers | K060195 |
| FEI number | 1713683 |
At a glance
- 1–9 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