BEUDAMED
    FDA Recall Terminated

    NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator

    Recall: Z-0071-2008 · Initiated May 28, 2007

    Recall

    Recall Number
    Z-0071-2008
    Event Number
    48721
    Firm
    Neomedix Corp
    FEI Number
    3003698071
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 28, 2007
    Posted
    September 29, 2008
    Terminated
    September 29, 2008
    Address
    15042 Parkway Loop, Ste A, Tustin, CA, 92780-6528

    Description

    NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator

    Reason

    Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.

    Action

    On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you. The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.

    Distribution

    Nationwide to: CA, HI, IA, NY & PA

    Quantity

    7