Device recall
Z-0967-2019: Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0967-2019 |
|---|---|
| Recall event | 81979 |
| Product | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters. |
| Product code | FGE |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2020 |
| 510(k) numbers | K152524 |
| FEI number | 1820334 |
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