Device recall
Z-0339-2020: Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n…
FDA device recall · Class II · Western / Scott Fetzer Company
Key facts
| Recall number (Z-number) | Z-0339-2020 |
|---|---|
| Recall event | 83857 |
| Product | Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for… |
| Product code | ECX |
| Recalling firm | Western / Scott Fetzer Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2020 |
| 510(k) numbers | K142149 |
| FEI number | 1526809 |
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