BEUDAMED
    FDA Recall Terminated

    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

    Recall: Z-2192-2014 · Initiated May 28, 2014

    Recall

    Recall Number
    Z-2192-2014
    Event Number
    68443
    Firm
    Childrens Medical Ventures
    FEI Number
    3007056120
    Product Code
    FMP
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 28, 2014
    Posted
    August 20, 2014
    Terminated
    November 29, 2016
    Address
    191 Wyngate Dr, Monroeville, PA, 15146-3045

    Description

    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

    Reason

    The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.

    Action

    Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:

    Distribution

    Worldwide Distribution - USA (nationwide) including the country of Canada.

    Quantity

    332,649