BEUDAMED
    FDA Recall Terminated

    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

    Recall: Z-2452-2020 · Initiated April 24, 2020

    Recall

    Recall Number
    Z-2452-2020
    Event Number
    85623
    Firm
    LivaNova USA Inc.
    FEI Number
    1718850
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 24, 2020
    Terminated
    February 17, 2022
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

    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.

    Action

    The firm sent an URGENT MEDICAL DEVICE REMOVAL letter to affected customers on 04/24/2020. The purpose of this medical device correction is to: 1. Advise the customers of the present issue and not to use the affected devices; 2. Providing information to the user on product disposal or return and replacement; 3. Inform affected customers that LivaNova will coordinate replacement for the unused products.

    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

    96 units