BEUDAMED
    FDA Recall Terminated

    Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.

    Recall: Z-1950-2011 · Initiated December 5, 2008

    Recall

    Recall Number
    Z-1950-2011
    Event Number
    57815
    Firm
    Heart Sync, Inc
    FEI Number
    1317188
    Product Code
    MLN
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    December 5, 2008
    Posted
    April 12, 2011
    Terminated
    April 13, 2011
    Address
    5643 Plymouth Rd, Ann Arbor, MI, 48105-9586

    Description

    Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.

    Reason

    The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.

    Action

    The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.

    Distribution

    Nationwide Distribution

    Quantity

    2100 (210 cases of 10 each)