BEUDAMED
    FDA Recall Terminated

    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter

    Recall: Z-1618-2008 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-1618-2008
    Event Number
    47388
    Firm
    Boston Scientific Corp
    FEI Number
    3001236349
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 14, 2008
    Posted
    August 30, 2008
    Terminated
    January 8, 2011
    Address
    150 Baytech Drive, San Jose, CA, 95134

    Description

    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter

    Reason

    Package sterile barrier may be breached, compromising sterility.

    Action

    Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or [email protected].

    Distribution

    Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.

    Quantity

    827 units total