BEUDAMED
    FDA Enforcement Class I Ongoing

    Drager SafeStar 55, Catalog No. MP01790

    Recall: Z-1211-2022 · Reported June 22, 2022

    Enforcement

    Recall Number
    Z-1211-2022
    Event ID
    90192
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2022
    Initiation Date
    May 16, 2022
    Classification Date
    June 10, 2022
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Drager SafeStar 55, Catalog No. MP01790

    Reason

    Possible occlusion of filters due to manufacturing error.

    Code Info

    UDI-DI: 04048675026785; Lot No. LT2103.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.

    Quantity

    35,950