BEUDAMED
    FDA Enforcement Class II Terminated

    Karma Flexx Wheelchair Manual Wheelchair.

    Recall: Z-1025-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1025-2016
    Event ID
    73159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karman Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    January 27, 2016
    Classification Date
    February 27, 2016
    Termination Date
    June 29, 2016
    Address
    19255 San Jose Ave, N/A, City of Industry, CA, 91748-1418, United States

    Description

    Karma Flexx Wheelchair Manual Wheelchair.

    Reason

    Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.

    Code Info

    Item # 935-0245H6 Flexx (KM852216) Serial # TM14-A03982-TM14-A03991 Item # 935-0246H6 Flexx (KM852218) Serial # TM14-A03992-TM14-A04012 Item # 935-0247H6 Flexx (KM852220) Serial # TM14-A4013-TM14-A04017

    Distribution

    U.S. distribution to the following states -- WA, CA, NY, and TX.

    Quantity

    35