BEUDAMED
    FDA Recall Terminated

    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.

    Recall: Z-1315-2016 · Initiated February 25, 2016

    Recall

    Recall Number
    Z-1315-2016
    Event Number
    73381
    Firm
    Scottcare Corporation
    FEI Number
    1527715
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 25, 2016
    Terminated
    February 15, 2019
    Address
    4791 W 150th St, Cleveland, OH, 44135-3301

    Description

    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.

    Reason

    The firm received a complaint of the battery exploding while recharging.

    Action

    On 2/26/2016 the firm sent "Urgent: TeleSentry Battery Recall" notification letters to their customers. The letter identified the affected device and the reason for the recall. Customers were asked to immediately examine their inventory and quarantine the affected device. If the product had been further distributed, then a copy of the letter should be provided to those customers. Customers are to follow the steps provided for returning the affected device, including contacting ScottCare Service at 1-800-243-9412. In addition, the attached response form should be completed and returned. Questions should be directed to ScottCare Customer Service at 1-800-243-9412.

    Distribution

    Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; and, the country of Canada.

    Quantity

    9,067 batteries