BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2530-2017 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2530-2017
    Event Number
    77406
    Firm
    Creganna Medical Devices Parkmore West Galway Ireland
    FEI Number
    3004193842
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 22, 2017
    Terminated
    May 29, 2018

    Description

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

    Reason

    Lack of sterility assurance.

    Action

    The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.

    Distribution

    Distributed in MA.

    Quantity

    150 units