BEUDAMED
    FDA Recall Terminated

    Sarns MP4 Cardioplegia Sets; catalog number 15501.

    Recall: Z-0664-03 · Initiated February 25, 2003

    Recall

    Recall Number
    Z-0664-03
    Event Number
    25714
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 25, 2003
    Posted
    March 20, 2003
    Terminated
    June 6, 2003
    Address
    6200 Jackson Rd., Ann Arbor, MI, 48103

    Description

    Sarns MP4 Cardioplegia Sets; catalog number 15501.

    Reason

    There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.

    Action

    Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.

    Distribution

    United States

    Quantity

    300