BEUDAMED
    FDA Recall Terminated

    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

    Recall: Z-2137-2016 · Initiated January 19, 2016

    Recall

    Recall Number
    Z-2137-2016
    Event Number
    74078
    Firm
    Ergoactives, Llc
    FEI Number
    3007084179
    Product Code
    IRT
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 19, 2016
    Terminated
    October 13, 2017
    Address
    20725 NE 16th Ave, Ste A26, Miami, FL, 33179-2132

    Description

    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

    Reason

    Products are marketed without a cleared 510k.

    Action

    Customers were notified by phone on 01/19/2016. Two follow-up notifications were sent to customers via e-mail. Customers were asked to immediately examine their inventory for the affected product; and, to notify and identify any customers they may have further distributed to. Ergoactives LLC requests that all Heaterbaum products be sent back to their headquarters: 20725 NE 16th Avenue, Suite A-26, Miami, FL 33179, along with the order number and note of where the product was purchased. The enclosed response form should be completed and returned as well. If customers have any questions, they can call Ergoactives LLC at (305)359-5031. Customers will receive a full refund for the return of their Heaterbaum products.

    Distribution

    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.

    Quantity

    278 units