BEUDAMED
    FDA Recall Terminated

    Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210

    Recall: Z-0127-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0127-2007
    Event Number
    36426
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    November 2, 2006
    Terminated
    August 12, 2009
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210

    Reason

    Biological indicator failed. Investigation eliminated all equipment and product related factors.

    Action

    Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

    Distribution

    Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand

    Quantity

    830 units