BEUDAMED
    FDA Enforcement Class II Terminated

    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

    Recall: Z-2717-2014 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2717-2014
    Event ID
    68329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2014
    Initiation Date
    May 19, 2014
    Classification Date
    September 29, 2014
    Termination Date
    September 18, 2015
    Address
    6203 Farinon Dr, N/A, San Antonio, TX, 78249-3441, United States

    Description

    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

    Reason

    Blade can shift during shipping which makes the product ineffective.

    Code Info

    Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000. Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000, 3247170000, 3247250000, 3247310000, 3247470000, 324780000, 3247810000, 3247820000, 3247960000, 3247970000, 3248080000, 3248190000, 3248230000, 3248300000, 3248380000, 3248960000, 3248970000, 3248980000, 3248990000, 3249000000, 3249010000, 3249020000, 3249030000, 3249040000, 3249050000, 3249060000, 3249070000, 3249080000, 3249090000, 3249100000, 3249110000, 3249390000, 3249580000.

    Distribution

    US nationwide Distribution

    Quantity

    1,331 units