BEUDAMED
    FDA Enforcement Class I 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 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0206-2015
    Event ID
    69568
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 10, 2014
    Classification Date
    November 21, 2014
    Termination Date
    November 29, 2016
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    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

    Code Info

    All lot codes

    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