BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2717-2014 · Initiated May 19, 2014

    Recall

    Recall Number
    Z-2717-2014
    Event Number
    68329
    Firm
    KCI USA, Inc.
    FEI Number
    3005178245
    Product Code
    GFD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 19, 2014
    Posted
    September 29, 2014
    Terminated
    September 18, 2015
    Address
    6203 Farinon Dr, San Antonio, TX, 78249-3441

    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.

    Action

    KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions. Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s). Option 2: If you prefer, you may re-set the blade after removal from the packaging by gently tapping the curved end of the harvester against the palm of your hand, as shown in Figure 3, until the blade is no longer visible in the harvester top plate, as shown in Figure 4.

    Distribution

    US nationwide Distribution

    Quantity

    1,331 units