Device recall
Z-1298-06: CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-1298-06 |
|---|---|
| Recall event | 35754 |
| Product | CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390. |
| Product code | NKE |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2008 |
| PMA numbers | P030005 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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