Device recall
Z-1642-2015: DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product…
FDA device recall · Class II · DeRoyal Industries Inc
Key facts
| Recall number (Z-number) | Z-1642-2015 |
|---|---|
| Recall event | 71193 |
| Product | DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity. |
| Product code | GCJ |
| Recalling firm | DeRoyal Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 29, 2015 |
| 510(k) numbers | K132375 |
| FEI number | 1043214 |
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