BEUDAMED
    FDA Enforcement Class II Terminated

    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

    Recall: Z-2461-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2461-2015
    Event ID
    71556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ferno-Washington Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 2, 2015
    Initiation Date
    May 1, 2015
    Classification Date
    August 25, 2015
    Termination Date
    November 6, 2015
    Address
    70 Weil Way, N/A, Wilmington, OH, 45177-9371, United States

    Description

    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

    Reason

    The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.

    Code Info

    Serial numbers: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730.

    Distribution

    Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.

    Quantity

    26 units