BEUDAMED
    FDA Enforcement Class II Terminated

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    Recall: Z-0378-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0378-2014
    Event ID
    66561
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mizuho America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    October 10, 2013
    Classification Date
    November 22, 2013
    Termination Date
    January 13, 2014
    Address
    30057 Ahern Ave, N/A, Union City, CA, 94587-1234, United States

    Description

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    Reason

    Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

    Code Info

    Product Code 17-001-58; Lot No. 29JY

    Distribution

    Nationwide Distribution

    Quantity

    35