Device recall
Z-1830-2015: LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1830-2015 |
|---|---|
| Recall event | 71287 |
| Product | LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or… |
| Product code | KGY |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 12, 2016 |
| 510(k) numbers | K910914 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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