BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100

    Recall: Z-2530-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2530-2017
    Event ID
    77406
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Creganna Medical Devices
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2017
    Initiation Date
    May 22, 2017
    Classification Date
    June 13, 2017
    Termination Date
    May 29, 2018
    Address
    Parkmore West, N/A, Galway, N/A, N/A, Ireland

    Description

    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100

    Reason

    Lack of sterility assurance.

    Code Info

    Lot # 383271, 384264

    Distribution

    Distributed in MA.

    Quantity

    150 units