Z-0340-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- August 15, 2019
- Termination Date
- November 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143,164 units
Product Description
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.
Reason for Recall
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
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.
Code Information
All Lot manufactured from 08/31/14 to 08/07/2019