Events

Retiro De Equipo (Recall) de Device Recall INTROFLEX VALVE INTRODUCER

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
    52629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1913-2009
  • Fecha de inicio del evento
    2009-05-11
  • Fecha de publicación del evento
    2009-08-25
  • 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=83492
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Edwards lifesciences llc received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
  • Acción
    Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.

Device

Device Recall INTROFLEX VALVE INTRODUCER
  • Modelo / Serial
    Model Number: 1350BF85, Lot Numbers:  58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016;  Model Number: 1351BF7, Lot Numbers: 58530069, 58545403, 58598947 and 58657088;  Model Number: 1351BF85H, Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097;  Model Number: 1450BF85, Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; Model Number: 1451BF6, Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035;  Model Number: 1451BF8, Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275;  Model Number: 1452BF85H, Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; Model Number: 1550BF6C, Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; Model Number: 1550BF7C, Lot Numbers: 58564227, 58577700 and 58657145; Model Number: 1550BF8, Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; Model Number: 1550BF85, Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; Model Number: 1551BF85H, Lot Numbers: 58615062, 58630987 and 58652699; Model Number: 1650BF85, Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; Model Number: 1651BF85, Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; Model Number: 1652BF85H, Lot Numbers:  58511631, 58549300, 58606253 and 58648812; Model Number: S310740C, Lot Number: 58550203; and Model Number: S5507BF85, Lot Numbers: 58496258, 58535112, 58604814 and 58644423.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.
  • Descripción del producto
    Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. || Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

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