BEUDAMED
    FDA Recall Terminated

    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.

    Recall: Z-0206-2015 · Initiated October 10, 2014

    Recall

    Recall Number
    Z-0206-2015
    Event Number
    69568
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    FMP
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    October 10, 2014
    Posted
    December 16, 2014
    Terminated
    November 29, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.

    Reason

    Mold on gel filled Gel-E and Squishon products

    Action

    Philips Healthcare/Children's Medical Ventures issued a Medical Device Recall Letter dated Oct 10, 2014. Customers were asked to discontinue use and dispose of all product in their facility, even if mold is not visible. Following these actions, customers will be asked to return a reply form indicating that these actions have been completed. Customers will be given credit for all disposed products. Further, the Gel-E Donut and Squishon 2 products will be withdrawn from the market. Customers with questions were instructed to contact their Philips/Children's Medical Ventures representative. For questions regarding this recall call 978-687-1501.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.

    Quantity

    336,695 units