BEUDAMED
    FDA Enforcement Class II Terminated

    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals

    Recall: Z-1397-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1397-2015
    Event ID
    70368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2015
    Initiation Date
    May 1, 2013
    Classification Date
    April 7, 2015
    Termination Date
    June 14, 2016
    Address
    75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals

    Reason

    Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

    Code Info

    Product with no lot/ expiration date on the product label

    Distribution

    Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES

    Quantity

    4,807,566