BEUDAMED
    FDA Enforcement Class II Ongoing

    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

    Recall: Z-1907-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1907-2024
    Event ID
    94437
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2024
    Initiation Date
    April 23, 2024
    Classification Date
    May 28, 2024
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

    Reason

    Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

    Code Info

    Catalog/UDI-DI/Lot: 90485/00815742004854/213869; 90495/00815742004953/134165, 134840, 135021, 138245, 172663, 172664, 173281, 175682, 176460, 176461, 177614, 178201, 178720, 213152

    Distribution

    Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    2579