BEUDAMED
    FDA Recall Terminated

    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.

    Recall: Z-0158-2015 · Initiated March 1, 2011

    Recall

    Recall Number
    Z-0158-2015
    Event Number
    58185
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1000149028
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 1, 2011
    Posted
    October 31, 2014
    Terminated
    November 6, 2014
    Address
    28 Howe St, Ashland, MA, 01721-1305

    Description

    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.

    Reason

    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

    Action

    Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.

    Distribution

    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

    Quantity

    777 units