Western / Scott Fetzer Company: Medical Device Recall in 2019 - (Recall #: Z-0342-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 15, 2019

Date Posted: November 13, 2019

Recall Number: Z-0342-2020

Event ID: 83857

Reason for Recall:

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

Status: Terminated

Product Quantity: 25,840 units

Code Information:

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated