BEUDAMED
    FDA Recall Terminated

    Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector

    Recall: Z-0053-2012 · Initiated September 13, 2011

    Recall

    Recall Number
    Z-0053-2012
    Event Number
    59912
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 13, 2011
    Posted
    October 17, 2011
    Terminated
    December 10, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.

    Action

    On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.

    Distribution

    Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.

    Quantity

    9770