BEUDAMED
    FDA Enforcement Class II Terminated

    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

    Recall: Z-1317-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1317-2016
    Event ID
    73281
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 10, 2016
    Classification Date
    April 4, 2016
    Termination Date
    August 1, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur

    Reason

    eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

    Code Info

    All in distribution.

    Distribution

    Nationwide distribution to Ohio only.

    Quantity

    539.156