BEUDAMED
    FDA Recall Terminated

    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

    Recall: Z-2689-2014 · Initiated July 31, 2014

    Recall

    Recall Number
    Z-2689-2014
    Event Number
    68955
    Firm
    Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
    FEI Number
    3008002452
    Product Code
    BZE
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 31, 2014
    Posted
    September 23, 2014
    Terminated
    February 8, 2016

    Description

    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

    Reason

    The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.

    Action

    CareFusion sent an URGENT: PRODUCT RECALL letters dated July 31, 2014 to all affected customers. The letters instructed customers to: 1) perform a 100% physical inventory to verify if any of the affected product codes are in stock; 2) complete and return the attached Recall Response Form within 15 days; 3) notify any customers/parties that the recalled products were distributed to of the recall; 4) distributors should have all their customers return the products and a completed Recall Response Form to the distributor for credit; and, 5) customers should destroy the recalled products according to their disposal procedure. If a customers procedure(s) does not allow for the destruction of the recalled products, the customers was advised to contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for product return options. Customers will receive credit for all destroyed products. Direct accounts with questions about this recall should contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for additional information.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.

    Quantity

    Approximately 318,280 devices