BEUDAMED
    FDA Recall Terminated

    8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40

    Recall: Z-1050-06 · Initiated April 5, 2006

    Recall

    Recall Number
    Z-1050-06
    Event Number
    35236
    Firm
    Medtronic, Inc.
    FEI Number
    1220452
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2006
    Posted
    June 1, 2006
    Terminated
    June 20, 2007
    Address
    35 37A Cherry Hill Dr, Danvers, MA, 01923-2565

    Description

    8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40

    Reason

    Potential for non-sterility due to loss of package integrity

    Action

    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

    Distribution

    Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.

    Quantity

    55 units