BEUDAMED
    FDA Enforcement Class II Ongoing

    TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

    Recall: Z-2327-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2327-2021
    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-226 (990226.SPE)

    Reason

    Potential for leaks and loosening at the patient catheter connection

    Code Info

    GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E

    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

    4980 sets