BEUDAMED
    FDA Recall Terminated

    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Recall: Z-1408-2015 · Initiated March 30, 2015

    Recall

    Recall Number
    Z-1408-2015
    Event Number
    70927
    Firm
    VasoNova, Inc.
    FEI Number
    3005747797
    Product Code
    OBJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2015
    Posted
    April 9, 2015
    Terminated
    April 11, 2016
    Address
    155 Jefferson Dr, Menlo Park, CA, 94025-1114

    Description

    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Reason

    A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letters dated on March 30, 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. The risk to users is identified and users are asked to discontinue use and quarantine affected serial numbers. Teleflex sales reps will help with return of product. The Acknowledgeable form should be completed and returned as per instructions. Questions should be directed to 1.877.236.6869.

    Distribution

    US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.

    Quantity

    17