BEUDAMED
    FDA Enforcement Class II Ongoing

    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.

    Recall: Z-1318-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1318-2023
    Event ID
    91841
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    February 10, 2023
    Classification Date
    March 31, 2023
    Address
    6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States

    Description

    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.

    Reason

    Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

    Code Info

    Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX

    Distribution

    U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada

    Quantity

    12,310 devices