Device recall
Z-2436-2010: The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of…
FDA device recall · Class II · Gyrus Acmi, Incorporated
Key facts
| Recall number (Z-number) | Z-2436-2010 |
|---|---|
| Recall event | 56626 |
| Product | The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray. |
| Product code | GCJ |
| Recalling firm | Gyrus Acmi, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2012 |
| 510(k) numbers | K923945 |
| FEI number | 3003790304 |
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