Western / Scott Fetzer Company recalls Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery…

Recall date

August 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0341-2020

FDA classification

Class II

Brand / firm

Western / Scott Fetzer Company

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Grab n Go Opti series VIPR system Model # PRX-9632 - 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.