BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated November 2, 2022

    Recall

    Recall Number
    Z-0371-2023
    Event Number
    91103
    Firm
    Bunnell, Inc.
    FEI Number
    3032745446
    Product Code
    LSZ
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    November 2, 2022
    Posted
    December 3, 2022
    Address
    436 W Lawndale Dr, Salt Lake City, UT, 84115-2917

    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.

    Action

    On 11/02/22, recall notices were emailed to customers, who were asked to remove the affected adapters and affected adapters from patient circuit kits and discard. The remainder of the Patient Circuit Kit may be retained for future use. As a reminder, customers may use a 3.0 mm LifePort Adapter (included in each Patient Circuit Kit) to connect to a 2.5 mm endotracheal tube if this is the only available product for patient care, per the instructions for use in the User Manual (model 204) and Operator's Manual (model 203). Complete are return the acknowledgement and receipt form. Customers with additional questions are encouraged to call 800-800-4358 or email [email protected]

    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