BEUDAMED
    FDA Recall 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 · Initiated May 1, 2013

    Recall

    Recall Number
    Z-1397-2015
    Event Number
    70368
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 1, 2013
    Posted
    April 7, 2015
    Terminated
    June 14, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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

    Action

    CooperSurgical sent a formal recall notification letter dated April 4, 2015 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical notified consignees affected by this recall via Fedex with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. CooperSurigcal will replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Contact CooperSurgical at 203 601 5200 Ext. 3100 if you have questions. Previously CooperSurgical notified consignees affected by this recall on 5/1/13.

    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