Device recall
Z-1996-2016: EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-1996-2016 |
|---|---|
| Recall event | 71372 |
| Product | EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of… |
| Product code | GEL |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2017 |
| FEI number | 2210968 |
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