BEUDAMED
    FDA Enforcement Class I Terminated

    Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management

    Recall: Z-2317-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2317-2019
    Event ID
    83461
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    July 30, 2019
    Classification Date
    September 9, 2019
    Termination Date
    February 15, 2022
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management

    Reason

    Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

    Code Info

    Batch numbers: 73K1600156 73K1600735 73L1600501 73A1700120 73B1700321 73C1700425 73D1700630 73E1700504 73G1700146 73H1700053 73J1700307 73K1700085 73B1800223 73B1800371 73C1800372 73D1800655 73E1800579 73G1800627 73H1800203 73H1800429 73H1800758 73J1800118 73J1800696

    Distribution

    US Nationwide Distribution

    Quantity

    77136 units