FDA Device recall Z-0343-2020
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to… by Western Scott Fetzer, citing limited access to flow settings as a result of the control knob having been rotated beyond its functional range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0343-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-15 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Western Scott Fetzer |
| Distribution | US |
Product
Grab n Go Opti series VIPR system Model # PRX-9653 - 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 emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
Reason
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Identifiers
| code_info | All Lot manufactured from 08/31/14 to 08/07/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0343-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.