BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.

    Recall: Z-0002-2010 · Initiated June 22, 2009

    Recall

    Recall Number
    Z-0002-2010
    Event Number
    52834
    Firm
    Edwards Lifesciences, Llc
    FEI Number
    2015691
    Product Code
    MFC
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    June 22, 2009
    Posted
    November 10, 2009
    Terminated
    February 23, 2012
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.

    Reason

    Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube.

    Action

    Edwards initiated a worldwide recall via customer letter dated June 29, 2009, sent via Federal express on same day, requesting that customers cease using Fogarty Occlusion Catheter, Model No. 62080822F products from the indicated lots and that they return all unused products. Edwards requested that the customers provide written verification of stock and identify any unused products to be returned to Edwards Lifesciences LLC, Att: Field Action Coordinator, ODW Logistics, Inc., 13725 Pipeline Ave., Chino, CA 91710. Additionally provided Customer Service Tel # 800.424.3278.

    Distribution

    AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MO NC ND NE NH NJ NM NV NK OH OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico Australia, Belgium, Brazil, Bulgaria, Canada, Canary Island, China, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Ireland, Italy, Japan, Luxembourg, Netherland, New Zealand, Poland, Portugal, Rumania, Russia, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and Turkey.

    Quantity

    9548