BEUDAMED
    FDA Enforcement Class II Terminated

    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

    Recall: Z-0784-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0784-2013
    Event ID
    63390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lansinoh Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    August 14, 2012
    Classification Date
    February 4, 2013
    Termination Date
    March 8, 2013
    Address
    333 N Fairfax St Ste 400, N/A, Alexandria, VA, 22314-2632, United States

    Description

    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

    Reason

    The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.

    Code Info

    Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01

    Distribution

    Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.

    Quantity

    51,472 units