Device recall
Z-1635-2014: Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product…
FDA device recall · Class II · Microline Surgical
Key facts
| Recall number (Z-number) | Z-1635-2014 |
|---|---|
| Recall event | 68012 |
| Product | Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto… |
| Product code | GEI |
| Recalling firm | Microline Surgical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2015 |
| 510(k) numbers | K981389 |
| FEI number | 1000137656 |
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