BEUDAMED
    FDA Enforcement Class I Terminated

    Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management

    Recall: Z-1759-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1759-2019
    Event ID
    82964
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    May 24, 2019
    Classification Date
    June 19, 2019
    Termination Date
    February 15, 2022
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management

    Reason

    This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

    Code Info

    Lot Numbers: 73K1600369, 73L1600011, 73A1700646, 73C1700238, 73D1700625, 73E1700475, 73F1700387, 73H1700041, 73H1700483, 73J1700292, 73L1700503, 73M1700453, 73A1800671, 73B1800350, 73D1800138, 73F1800174, 73G1800126, 73G1800806, 73J1800308, 73K1800173, 73L1800225, 73K1800172

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    3483 units