BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

    Recall: Z-1494-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1494-2025
    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: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

    Reason

    The potential for cracks forming in the breathing circuit hose.

    Code Info

    Model/Catalog Number: MP01347; UDI Number 04048675249337; 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

    3325 units