Device recall
Z-1409-2017: Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1409-2017 |
|---|---|
| Recall event | 76327 |
| Product | Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures |
| Product code | MMP |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2019 |
| 510(k) numbers | K041501 |
| FEI number | 1219930 |
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