Device recall
Z-2448-2012: Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-2448-2012 |
|---|---|
| Recall event | 63100 |
| Product | Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree. |
| Product code | DQY |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2013 |
| 510(k) numbers | K902256 |
| FEI number | 2027111 |
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