BEUDAMED
    FDA Enforcement Class II Terminated

    Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

    Recall: Z-1232-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1232-2017
    Event ID
    76346
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 1, 2017
    Initiation Date
    January 5, 2015
    Classification Date
    February 22, 2017
    Termination Date
    February 23, 2017
    Address
    125 Blue Ball Rd, N/A, Elkton, MD, 21921-5315, United States

    Description

    Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.

    Code Info

    Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R

    Distribution

    The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.

    Quantity

    1463