BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)

    Recall: Z-1934-2009 · Initiated March 14, 2008

    Recall

    Recall Number
    Z-1934-2009
    Event Number
    52802
    Firm
    Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic
    FEI Number
    3003081151
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 14, 2008
    Posted
    August 25, 2009
    Terminated
    July 3, 2012

    Description

    Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)

    Reason

    Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.

    Action

    Edwards initiated the recall in the U.S. via a Urgent Customer lNotification letter with attached response confirmation fax-back attachment dated March 10, 2008 and was sent by Federal Express on March 12, 2008 requesting that customers cease using all "VAMP Jr" products and that they return all unused product. Customers were instructed to fax-back the confirmation attachment to 800-422-9329 and contact Edwards Customer service at 888-570-4012 to arrange for return of any unused product and obtain information about replacement product. Edwards Lifesciences requested that the customer provide written verification of stock and identify and unused product to be returned. This will enable a 100% effectiveness check for this recall. For product that was shipped to distributors, contact was made directly from Edwards Lifesciences Corporate Office in Irvine, CA. All product that was distributed internationally will be handled regionally. (i.e. US, Canada, Europe/EMEA, Japan, Intercontinental-including Latin America and Asia Pacific)

    Distribution

    Worldwide Distribution including USA and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United Kingdom.

    Quantity

    61,199 units