BEUDAMED
    FDA Recall Terminated

    MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.

    Recall: Z-0182-2007 · Initiated August 29, 2006

    Recall

    Recall Number
    Z-0182-2007
    Event Number
    36470
    Firm
    Olsen Medical
    FEI Number
    3000719969
    Product Code
    JOS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2006
    Posted
    November 15, 2006
    Terminated
    July 26, 2011
    Address
    3001 W Kentucky St, Louisville, KY, 40211-1505

    Description

    MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.

    Reason

    Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.

    Action

    The firm issued an ''Urgent: Device Recall'' notification to their customers via letter and E-mail on 8/29/2006 and 8/30/2006. The letter informs the customers of this problem and asks that the customers contact their sub-accounts and notify them of the problem if they have further distributed any of the suspect part numbers. The letter also asks that the distributor/customer(s) have the subaccounts discontinue use of the product; and return the held product to the distributor (who in turn, should return the product to Olsen Medical for reimbursement). The customers are asked to complete and fax back to the recalling firm, an attached Acknowledgement form documenting receipt of the recall notification by the customer/employee with name and date received. The firm also asked that the customer supply information regarding the amount of inventory /shipped on a checklist. The amounts received are broken down on the Checklist by Lot Number with the amount of product in inventory and the amount of product shipped. These amounts are reported by the responders by ''pieces and cases'' on hand at the time that the notice was received.

    Distribution

    Worldwide, including USA, Japan, and New Zealand.

    Quantity

    81 cases/972 pieces