BEUDAMED
    FDA Enforcement Class I Terminated

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    Recall: Z-2370-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2370-2015
    Event ID
    71360
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    June 1, 2015
    Classification Date
    August 19, 2015
    Termination Date
    April 16, 2018
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    Reason

    The double swivel connector may crack or separate on the endobronchial tube.

    Code Info

    Product Code: 5-15401, Lot numbers: 01K1300254, 01L1300393, 01M1300212, 01A1400436, 01C1400086, 73D1400096, 73D1400496, 73E1400269, 73F1400153, 73F1400352, 73G1400052, 73G1400288, 73H1400331, 73J1400401, 73L1400106, 73M1400208, 73A1500345, 73B1500272 and 73C1500255.

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

    Quantity

    188,195 total units