Events

Retiro De Equipo (Recall) de Device Recall Fogaty Occlusion Catheter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Edwards Lifesciences, Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    52834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0002-2010
  • Fecha de inicio del evento
    2009-06-22
  • Fecha de publicación del evento
    2009-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84106
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter - Product Code MFC
  • Causa
    Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the dfu on the packaging tube.
  • Acción
    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.

Device

Device Recall Fogaty Occlusion Catheter
  • Modelo / Serial
    58315682 58315684 58319564 58323527 58329182 58329183 58330839 58331170 58337676 58339525 58344788 58404076 58404077 58412886 58423180 58425421 58430853 58432662 58437558 58439309 58442706 58448659 58450729 58457786 58461586 517BC705 58475993 58481176 58483920 58488640 58492016 58495186 58495187 58502966 58507300 58515391 58517396 58521823 58524823 58527272 58530759 58537870 58537877 58551761 58568073 58578112 58578113 58580168 58581724 58588472 58592000 517BC706 58597273 58599730 58604851 58605887 58613048 58616823 58618748 58620574 58623035 58629084 58632507 58651514 58652960 58659509 58664309 58664309 58669996 58669998 58672855 58679236 58679860 58684904 58685420 58689629 58692796 58696610 517BC706A 58698652 58714764 515A1101 515A1102 515E3348 515H4785 515J5246 515K5874 515K5875 515L6221 516C8181 516D8613 516D8614 516E9154 516E9155 516F9635 516F9636 516G0232 516H0993 516H0994 516J1347 516J1348 516K1910 516K1911 516L2483 516L2484 516M2875 516M2876 517A3353 517A3354 517B3889 517B3890 517CC149 517CC150 517CC151 517CC889 517CC890 517CC891 517D4948 517E5557 517F6110 517F6111 517F6112 517G6621 517G6622 517G6623 517G6623A 517H7139 517H7140 6U11L2232
  • Distribución
    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.
  • Descripción del producto
    Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. || The product is intended for use in Temporary Vessel Occlusion.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Dirección del fabricante
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA