BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0342-2020 · Initiated August 15, 2019

    Recall

    Recall Number
    Z-0342-2020
    Event Number
    83857
    Firm
    Western Scott Fetzer Company
    FEI Number
    1526809
    Product Code
    ECX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 15, 2019
    Terminated
    November 18, 2020
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142

    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.

    Reason

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

    Action

    Western formally communicated the product issue to Praxair on 7/12/19, who had been previously in contact with Western regarding this issue. Western plans to issue a formal communication to affected distributors in the near future. The firm has initiated corrective action in the field as of August 2019. The firm has implemented a new screening process at each fill plant to identify and isolate units that could potentially be rotated past the stop. Units which fail are isolated and returned to Western, which will inspect each failed unit, replace the failed component with the revised knob/plate, and return the refurbished unit to the fill plant. One customer specifically requested that, instead of the screening procedure above, all of its units in service be replaced with the revised design. Western fulfilled this request. On October 11, 2019, Western mailed a Medical Device Recall letter to its distributors to officially communicate the issue.

    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

    25,840 units