Device recall
Z-2800-2015: PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut…
FDA device recall · Class II · Zien Medical Technologies, Inc
Key facts
| Recall number (Z-number) | Z-2800-2015 |
|---|---|
| Recall event | 72038 |
| Product | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 |
| Product code | GDX |
| Recalling firm | Zien Medical Technologies, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2015 |
| FEI number | 3009756153 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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