Device recall
Z-2435-2012: Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-2435-2012 |
|---|---|
| Recall event | 63015 |
| Product | Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection… |
| Product code | GDW |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 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