BEUDAMED
    FDA Recall Terminated

    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    Recall: Z-0933-2015 · Initiated November 19, 2014

    Recall

    Recall Number
    Z-0933-2015
    Event Number
    69961
    Firm
    KCI USA, INC.
    FEI Number
    3009897021
    Product Code
    GFD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 19, 2014
    Posted
    January 7, 2015
    Terminated
    September 18, 2015
    Address
    12930 IH 10, West San Antonio, TX, 78249

    Description

    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    Reason

    KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.

    Action

    KCI sent an Urgent - Voluntary Medical Device Field Notification letter to all affected consignees on December 8, 2014. The letter notified the customer of the issue, and provided instructions to inspect their harvester prior to use. If blade drift is identified, instructionswere provided to the customer to either return the device to KCI, or if they wish, how to reset the blade prior to use. The letter instructs the customer to respond to the recall notifcation by returning the product reconciliation form attached the letter. Follow-up notifcations will be send to non-responding consignees. Consignees with questions were instructed to contact their local KCI Representative or Customer Technical Service Center at 1-800-275-4524 and select option 3. For questions regarding this recall call 210-515-4108.

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.

    Quantity

    1,139/5 Packs