BEUDAMED
    FDA Enforcement Class I Terminated

    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.

    Recall: Z-2174-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2174-2012
    Event ID
    62559
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nellcor Puritan Bennett Inc. (dba Covidien LP)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 18, 2012
    Classification Date
    August 10, 2012
    Termination Date
    January 22, 2015
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States

    Description

    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.

    Reason

    Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.

    Code Info

    United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X. Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    337,227 units