BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only

    Recall: Z-1497-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1497-2025
    Event ID
    96342
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    March 12, 2025
    Classification Date
    April 3, 2025
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only

    Reason

    The potential for cracks forming in the breathing circuit hose.

    Code Info

    Model/Catalog Number: MP02744; UDI Number 040486775389675; All lot numbers.

    Distribution

    Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom

    Quantity

    293660 units