Device recall
Z-0954-04: The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as…
FDA device recall · Class III · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-0954-04 |
|---|---|
| Recall event | 28980 |
| Product | The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths |
| Product code | FED |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 3, 2012 |
| 510(k) numbers | K982594 |
| FEI number | 1045254 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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