BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

    Recall: Z-2456-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2456-2020
    Event ID
    85623
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    April 24, 2020
    Classification Date
    June 26, 2020
    Termination Date
    February 17, 2022
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

    Reason

    The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

    Code Info

    LOT 2003400086

    Distribution

    US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)

    Quantity

    768 units