BEUDAMED
    FDA Recall Terminated

    VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.

    Recall: Z-0476-2009 · Initiated September 9, 2008

    Recall

    Recall Number
    Z-0476-2009
    Event Number
    49550
    Firm
    CTS, Inc. dba Guidant Cardiac Surgery
    FEI Number
    3000719698
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 9, 2008
    Posted
    December 23, 2008
    Terminated
    December 8, 2010
    Address
    170 Baytech Dr, San Jose, CA, 95134-2302

    Description

    VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.

    Reason

    Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.

    Action

    The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.

    Distribution

    Worldwide Distribution --- including USA and country of Australia.

    Quantity

    7,935 units