BEUDAMED
    FDA Enforcement Class I Terminated

    Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management

    Recall: Z-1763-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1763-2019
    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: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 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

    1) Uncuffed 6.0 mm, Product Code 5-10412 Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 2) Uncuffed 6.5 mm, Product Code 5-10413 Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 3) Uncuffed 7.0 mm, Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    14357