BEUDAMED
    FDA Recall Terminated

    Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)

    Recall: Z-0582-05 · Initiated January 14, 2005

    Recall

    Recall Number
    Z-0582-05
    Event Number
    30952
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 14, 2005
    Posted
    March 10, 2005
    Terminated
    August 19, 2005
    Address
    2345 Waukegan Rd, Suite 120, Bannockburn, IL, 60015

    Description

    Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)

    Reason

    Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.

    Action

    The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.

    Distribution

    Nationwide

    Quantity

    8,990 units