BEUDAMED
    FDA Enforcement Class II Terminated

    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    Recall: Z-0227-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0227-2020
    Event ID
    81108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    June 8, 2018
    Classification Date
    October 29, 2019
    Termination Date
    April 28, 2021
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    Code Info

    UPN: M00326310 Lot Numbers/UDI: 0000000563/ (01)04546540688743(17)201031(10)0000000563; 0000000986/ (01)04546540688743(17)201031(10)0000000986; 0000001646/ (01)04546540688743(17)201130(10)0000001646; 0000002238/ (01)04546540688743(17)201130(10)0000002238; 0000002426/ (01)04546540688743(17)201231(10)0000002426; 0000002640/ (01)04546540688743(17)201231(10)0000002640; 0000003465/ (01)04546540688743(17)210131(10)0000003465; 0000004906/ (01)04546540688743(17)210228(10)0000004906; 0000005147/ (01)04546540688743(17)210228(10)0000005147; 0000005343/ (01)04546540688743(17)210228(10)0000005343; 0000007637/ (01)04546540688743(17)210421(10)0000007637;

    Distribution

    Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

    Quantity

    831