BEUDAMED
    FDA Recall Terminated

    Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709

    Recall: Z-0585-2010 · Initiated November 25, 2009

    Recall

    Recall Number
    Z-0585-2010
    Event Number
    53937
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    CCL
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    November 25, 2009
    Posted
    December 29, 2009
    Terminated
    April 7, 2011
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709

    Reason

    Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment.

    Action

    Consignees were notified via next day delivery on or about 11/25/2009. Each customer received a letter requesting acknowledgement of the recall and a request to return the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second and third mailing to non-responding customers on the consignee list will be made, or as an alternative, the third contact may be by phone, e-mail, or fax. Affected products received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. Records of contacts and of destruction or rework will be maintained. Questions are directed to the company at 1-866-246-6990.

    Distribution

    FL, KY, MI, OH, PA, SD, TN, Australia and Canada.

    Quantity

    51 eaches