BEUDAMED
    FDA Enforcement Class II Terminated

    Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.

    Recall: Z-2669-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2669-2017
    Event ID
    77190
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sterilmed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    May 8, 2017
    Classification Date
    July 3, 2017
    Termination Date
    May 22, 2018
    Address
    5010 Cheshire Pkwy N Ste 2, N/A, Minneapolis, MN, 55446-4101, United States

    Description

    Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.

    Reason

    Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.

    Code Info

    all lots

    Distribution

    US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.

    Quantity

    963 devices