Device recall
Z-0991-2012: DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-0991-2012 |
|---|---|
| Recall event | 60901 |
| Product | DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection… |
| Product code | GDW |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2016 |
| 510(k) numbers | K080898 |
| FEI number | 1219930 |
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