BEUDAMED
    FDA Recall Terminated

    AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.

    Recall: Z-2386-2011 · Initiated April 4, 2011

    Recall

    Recall Number
    Z-2386-2011
    Event Number
    58431
    Firm
    Medela Inc
    FEI Number
    1419937
    Product Code
    OHH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 4, 2011
    Posted
    May 27, 2011
    Terminated
    October 16, 2012
    Address
    1101 Corporate Dr, Mchenry, IL, 60050-7006

    Description

    AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.

    Reason

    The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.

    Action

    Medela Inc., sent an " IMPORTANT FIELD ACTION " letter dated April 4, 2011, to all affected customers via The United States Postal Service ( USPS) United Parcel Service ( UPS) and E-mail .The letter identified the product, the problem, and the action to be taken by the customer. It was discovered the power adaptor/transformer used with the Pump in Style Advanced family of breast pumps can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the power cord. Use of the power adaptor with a damaged cord could result in a short in the cord resulting in sparks, smoke, burning and melting of the transformers. If the users have a damaged power adaptor or power adaptor cord, they were requested to discontinue use of the adaptor and visit Medela's website at www.poweradaptorhelp.com to request a replacement adaptor. Questions about the recall process were directed to Medela Customer Service at 1-855-367-0104 or e-mail at [email protected]. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelapoweradaptorhelp.com on April 4, 2011.

    Distribution

    Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti. CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district.

    Quantity

    17,681 units alone, 461,142 units with products