BEUDAMED
    FDA Enforcement Class II Ongoing

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    Recall: Z-2328-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2328-2021
    Event ID
    88369
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    July 23, 2021
    Classification Date
    August 19, 2021
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    Reason

    Potential for leaks and loosening at the patient catheter connection

    Code Info

    GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

    Quantity

    4200 sets