BEUDAMED
    FDA Recall Terminated

    Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item Number: 73381 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    Recall: Z-3226-2011 · Initiated August 11, 2011

    Recall

    Recall Number
    Z-3226-2011
    Event Number
    59704
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1000149028
    Product Code
    MJJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 11, 2011
    Posted
    September 16, 2011
    Terminated
    March 20, 2012
    Address
    28 Howe St, Ashland, MA, 01721-1305

    Description

    Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item Number: 73381 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    Reason

    3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves

    Action

    Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers. The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm. For questions on this recall contact Terumo Customer Service at (734) 525-9580.

    Distribution

    Nationwide Distribution, including the states of FL and MI.

    Quantity

    39 units