BEUDAMED
    FDA Recall Terminated

    Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.

    Recall: Z-2446-2010 · Initiated April 12, 2007

    Recall

    Recall Number
    Z-2446-2010
    Event Number
    56183
    Firm
    Chalgren Enterprises Inc
    FEI Number
    2939713
    Product Code
    IKT
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 12, 2007
    Posted
    September 21, 2010
    Terminated
    March 24, 2011
    Address
    380 Tomkins Ct, Gilroy, CA, 95020-3631

    Description

    Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.

    Reason

    Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.

    Action

    Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.

    Distribution

    Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.