BEUDAMED
    FDA Enforcement Class I Ongoing

    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

    Recall: Z-2159-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2159-2025
    Event ID
    97026
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 16, 2025
    Classification Date
    July 31, 2025
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

    Reason

    Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

    Code Info

    Mode No. MP05790; UDI: 04048675558736; All Lots.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.

    Quantity

    9,885,139 units