BEUDAMED
    FDA Recall Terminated

    LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.

    Recall: Z-0805-05 · Initiated April 29, 2005

    Recall

    Recall Number
    Z-0805-05
    Event Number
    31571
    Firm
    Laerdal Medical Corporation
    FEI Number
    2425852
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2005
    Posted
    May 12, 2005
    Terminated
    January 18, 2008
    Address
    167 Myers Corner Rd PO Box 1840, Wappingers Falls, NY, 12590-8840

    Description

    LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.

    Reason

    Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.

    Action

    Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only.

    Distribution

    Nationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution.

    Quantity

    At least 3,019 units sold in the U.S.