BEUDAMED
    FDA Recall Terminated

    Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.

    Recall: Z-1242-06 · Initiated May 18, 2006

    Recall

    Recall Number
    Z-1242-06
    Event Number
    35559
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 18, 2006
    Posted
    July 28, 2006
    Terminated
    May 14, 2007
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.

    Reason

    The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.

    Action

    Consignees were first contacted by phone with follow up letter sent via fax or mail on May 18, 2006. International consignees will be notified through the firm's regional offices.

    Distribution

    Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)

    Quantity

    95,639 electrode sets