BEUDAMED
    FDA Recall Terminated

    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.

    Recall: Z-0056-2007 · Initiated April 3, 2006

    Recall

    Recall Number
    Z-0056-2007
    Event Number
    36165
    Firm
    EM Innovations Inc
    FEI Number
    1000515375
    Product Code
    MMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 3, 2006
    Posted
    October 20, 2006
    Terminated
    February 21, 2007
    Address
    6106 Bausch Rd, Galloway, OH, 43119-9382

    Description

    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.

    Reason

    The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.

    Action

    The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.

    Distribution

    The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.

    Quantity

    2,462 units