Terminated

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

FDA Recall Z-0002-2010 · Posted 2009-11-10

Recalling FirmEdwards Lifesciences, Llc

Recall StatusTerminated

Product CodeMFC

Date Initiated2009-06-22

Date Terminated2012-02-23

Product Quantity9548

Reason for Recall

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

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.