Device recall
Z-2314-2017: LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2314-2017 |
|---|---|
| Recall event | 77167 |
| Product | LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures. |
| Product code | GCJ |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2019 |
| FEI number | 1820334 |
At a glance
- None 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