Device recall
Z-0640-2018: GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-0640-2018 |
|---|---|
| Recall event | 79154 |
| Product | GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide… |
| Product code | KNT |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 26, 2018 |
| 510(k) numbers | K143083, K160654 |
| 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