Device recall
Z-2721-2014: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and…
FDA device recall · Class II · Instrumed International, Inc.
Key facts
| Recall number (Z-number) | Z-2721-2014 |
|---|---|
| Recall event | 68725 |
| Product | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue… |
| Product code | GEI |
| Recalling firm | Instrumed International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2017 |
| 510(k) numbers | K060232 |
| FEI number | 1421101 |
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