BEUDAMED
    FDA Recall Terminated

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    Recall: Z-1661-2013 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1661-2013
    Event Number
    65493
    Firm
    DJO, LLC
    FEI Number
    2020737
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 28, 2013
    Posted
    July 3, 2013
    Terminated
    February 13, 2014
    Address
    1430 Decision, St Vista, CA, 92081-8553

    Description

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    Reason

    DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).

    Action

    DJO sent a Customer Notification letter dated May 28, 2013 to Domestic customers via USPS certified return receipt and to International customers via UPS on June 14, 2013. The Customer Notification informed customers of the product safety issue, product description, and instructions to follow. DJO plans to install replacement batteries at no charge. For questions contact your local DJO Customer Service Representative.

    Distribution

    Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula.

    Quantity

    2491