BEUDAMED
    FDA Recall Terminated

    Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

    Recall: Z-1232-2017 · Initiated January 5, 2015

    Recall

    Recall Number
    Z-1232-2017
    Event Number
    76346
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2015
    Posted
    February 22, 2017
    Terminated
    February 23, 2017
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    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.

    Action

    A recall notification is being forwarded to all users and consignees who have received product. The notification of this voluntary recall will be sent to the following consignee in each facility:+ Director of Operating Room Services Proposed Level of Effectiveness Checks: Terumo CVS will verify that 100% of all letters are delivered to affected consignees

    Distribution

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

    Quantity

    1463