BEUDAMED
    FDA Enforcement Class II Terminated

    Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,

    Recall: Z-2370-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2370-2020
    Event ID
    85497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2020
    Initiation Date
    March 25, 2020
    Classification Date
    June 15, 2020
    Termination Date
    July 12, 2021
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630, United States

    Description

    Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,

    Reason

    Incorrect expiration date

    Code Info

    Lot Number: 903224A; Device Identifier/GTIN 08717648227455

    Distribution

    US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee

    Quantity

    13 units