Device recall
Z-1740-2018: ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI…
FDA device recall · Class II · Microline Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1740-2018 |
|---|---|
| Recall event | 79435 |
| Product | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic… |
| Product code | GEI |
| Recalling firm | Microline Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 2019 |
| 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