BEUDAMED
    FDA Recall Terminated

    Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes.

    Recall: Z-2105-2011 · Initiated February 7, 2011

    Recall

    Recall Number
    Z-2105-2011
    Event Number
    58255
    Firm
    Neuro Resource Group Inc
    FEI Number
    3004786509
    Product Code
    GZJ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    February 7, 2011
    Posted
    April 28, 2011
    Terminated
    September 23, 2011
    Address
    1100 Jupiter Rd, Ste 190, Plano, TX, 75074-7047

    Description

    Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes.

    Reason

    Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.

    Action

    Triad Group issued a press release on 2/7/2011, and notified consignees by e-mail 3/2/2011. Neuro Resource Group, Inc. ( NRG ) removed the recalled Triad wipes from all kits in house and obtained non recalled wipes from an alternate supplier. For replacement wipes customers may contact NRG customer service at 1-877-314-6500.

    Distribution

    Worldwide Distribution

    Quantity

    57,252 wipes