BEUDAMED
    FDA Recall Terminated

    ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.

    Recall: Z-2051-2016 · Initiated June 13, 2016

    Recall

    Recall Number
    Z-2051-2016
    Event Number
    74445
    Firm
    Cardiovascular Systems Inc
    FEI Number
    3004742232
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 13, 2016
    Terminated
    August 16, 2016
    Address
    1225 Old Hwy 8 NW, Saint Paul, MN, 55112-6416

    Description

    ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.

    Reason

    The pouch label was missing the use by date (UBD) of 2018-04.

    Action

    Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.

    Distribution

    US Nationwide distribution.

    Quantity

    190 units (38 - 5 pack shelf cartons)