BEUDAMED
    FDA Recall 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 · Initiated March 5, 2014

    Recall

    Recall Number
    Z-1441-2014
    Event Number
    67752
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    DSA
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 5, 2014
    Posted
    April 9, 2014
    Terminated
    April 9, 2018
    Address
    6830 Meadowridge Ct, Alpharetta, GA, 30005-2202

    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 (-).

    Action

    Remington Medical Inc sent an Field Safety Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please be aware that the typographical error described above is included in the FL-601-97 Instructions for Use (RM-0154 Rev 05) provided with the lots that you have received as identified below. RMI has corrected the typographical error in the revised FL-601-97 Instructions for Use (RM-0154 Rev 5.1) which is attached to this communication. Please incorporate the information contained in the attachment with the existing FL-601-97 labeling (Instructions for Use) provided with the product. If you have distributed these products further, please forward copies of this notice and the revised Instructions for Use to any recipients as appropriate. If you have any questions regarding this communication, please contact RMIs sales representatives or customer service team at 800-989-0057, Monday - Friday, between the hours of 8 am - 4pm EST. Patient safety is the highest priority for Remington Medical, Inc. We appreciate your assistance with this matter and regret any inconvenience this may cause.

    Distribution

    USA (nationwide) Distribution including Canada

    Quantity

    41,499 cables