BEUDAMED
    FDA Enforcement Class II Terminated

    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.

    Recall: Z-1441-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1441-2014
    Event ID
    67752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remington Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    April 9, 2014
    Termination Date
    April 9, 2018
    Address
    6830 Meadowridge Ct, N/A, Alpharetta, GA, 30005-2202, United States

    Description

    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.

    Reason

    Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).

    Code Info

    Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.

    Distribution

    USA (nationwide) Distribution including Canada

    Quantity

    41,499 cables