Device recall
Z-1855-2018: (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC…
FDA device recall · Class II · COVIDIEN MEDTRONIC
Key facts
| Recall number (Z-number) | Z-1855-2018 |
|---|---|
| Recall event | 79974 |
| Product | (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously… |
| Product code | GDW |
| Recalling firm | COVIDIEN MEDTRONIC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2020 |
| 510(k) numbers | K111825 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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