Device recall
Z-0698-05: ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device…
FDA device recall · Class II · Wilson-Cook Medical Inc
Key facts
| Recall number (Z-number) | Z-0698-05 |
|---|---|
| Recall event | 31553 |
| Product | ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook… |
| Product code | GCJ |
| Recalling firm | Wilson-Cook Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2005 |
| 510(k) numbers | K011016 |
| FEI number | 1037905 |
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