BEUDAMED
    FDA Enforcement Class II Terminated

    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

    Recall: Z-0543-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0543-2016
    Event ID
    72681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 20, 2015
    Classification Date
    December 24, 2015
    Termination Date
    August 7, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

    Reason

    Heel warmers may cause first and second degree burns.

    Code Info

    All product in distribution

    Distribution

    Moberly, MO

    Quantity

    7,327,100 individual units