BEUDAMED
    FDA Enforcement Class II Ongoing

    2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938

    Recall: Z-0371-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0371-2023
    Event ID
    91103
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bunnell, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    November 2, 2022
    Classification Date
    December 2, 2022
    Address
    436 W Lawndale Dr, N/A, Salt Lake City, UT, 84115-2917, United States

    Description

    2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938

    Reason

    Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.

    Code Info

    Catalog/UDI/Lot: 9025/10616120000034/22042320 ; and 2.5 mm LifePort Endotracheal Tube Adaptors, Lot: 22042320, inside 938/10616120000089, 00616120000082/22052381, 22052407, 22062431, 22062458, 22062478

    Distribution

    US Nationwide Distribution: PA, NY, AR, AZ, TN, SC, MA, FL, CA, TX, MD, VA, NV, IL, IN, IA, HI, KY, LA, WI, GA, OH, MI, MO, MN, NJ, MS, NC, ND, NM, UT, OK, WA, RI; OUS: Canada

    Quantity

    1606 Assemblies