Device recall
Z-1147-2018: DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-1147-2018 |
|---|---|
| Recall event | 79355 |
| Product | DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced… |
| Product code | OMO |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2019 |
| 510(k) numbers | K133864 |
| FEI number | 2210968 |
At a glance
- 1–9 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