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Western / Scott Fetzer Company recalls Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated deliver
Recalled November 13, 2019 · FDA recall Z-0340-2020 · Western / Scott Fetzer
Hazard
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range · FDA Class II
Units
143,164 units
Sold at
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.
Description
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Product
Grab n Go Opti series VIPR system Model # PRX-9627 - 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.
Manufacturer(s)
Western / Scott Fetzer Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →