# FDA recall Z-0342-2020

> **Western / Scott Fetzer Company** · Class II · device recall initiated 2019-08-15.

## Product

Grab  n Go Opti series VIPR system  Model # PRX-9646 - 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 for recall

Limited access to flow settings as a  result of the control knob having been rotated beyond its functional range

## Distribution

Worldwide distribution  US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.

## Key facts

- **Recall number:** Z-0342-2020
- **Recalling firm:** Western / Scott Fetzer Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-15
- **Report date:** 2019-11-13
- **Termination date:** 2020-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westlake, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2020

## Citation

> AI Analytics. FDA recall Z-0342-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0342-2020. Source: US FDA. Licensed CC0.

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