BEUDAMED
    FDA Enforcement Class II Terminated

    Grab n Go Opti series VIPR system Model # PRX-9615 - 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.

    Recall: Z-0339-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0339-2020
    Event ID
    83857
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Western / Scott Fetzer Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 13, 2019
    Initiation Date
    August 15, 2019
    Classification Date
    November 6, 2019
    Termination Date
    November 18, 2020
    Address
    875 Bassett Rd, N/A, Westlake, OH, 44145-1142, United States

    Description

    Grab n Go Opti series VIPR system Model # PRX-9615 - 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

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

    Code Info

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

    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.

    Quantity

    1,287 units