Device recall
Z-0994-2012: DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-0994-2012 |
|---|---|
| Recall event | 60901 |
| Product | DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and… |
| 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