Device recall
Z-1408-2017: Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1408-2017 |
|---|---|
| Recall event | 76327 |
| Product | Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 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