Events

Retiro De Equipo (Recall) de Device Recall Guidant ACROBAT Vacuum Stabilizer

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 Guidant Cardiac Surgery.

¿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
    37272
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0611-2007
  • Fecha de inicio del evento
    2006-12-01
  • Fecha de publicación del evento
    2007-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50234
  • 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
    Vacuum Stabilizer - Product Code MWS
  • Causa
    Vacuum tubing failure- vacuum tubing fails before the labeled two year shelf life. this may result in partial or complete vacuum loss during surgery.
  • Acción
    The firm has issued by FedEx letters dated 12/1/2006, to all consignees who received the product in the US, and has also informed their foreign distributors in the same manner on December 4, 2006. The firm''s field representatives were notified via teleconference on December 1, 2006. A hard copy of the notice was delivered to field reps on December 4 as well.

Device

Device Recall Guidant ACROBAT Vacuum Stabilizer
  • Modelo / Serial
    All products with expiry dates of June 2008, lot codes ranging from 4120181 to 6100281.   See below.   5042281 5071983 5041981 5090881 5102481 5120581 6020881 6050281 6061581 6080581 6091281 4120181 5042581 5072181 5051881 5091281 5102482 5120681 6021081 6050381 6061981 6080781 6091381 4120381 5042981 5072281 5051981 5091381 5102581 5120781 6021381 6050681 6062081 6080881 6091382 4120681 5050281 5072681 5052181 5091481 5102681 5120881 6021581 6050881 6062181 6080882 6091481 4120781 5050381 5072781 5053181 5091981 5102682 5120981 6021681 6051081 6062281 6080981 6092081 4120881 5050481 5072782 5060281 5091982 5102781 5121481 6022281 6051181 6062381 6080982 6092181 4121081 5051081 5080381 5060381 5092081 5102881 5121981 6022781 6051281 6062382 6081081 6092681 4121381 5051181 5080382 5060681 5092082 5102882 5121982 6022782 6051381 6062681 6081082 6092781 4121481 5051281 5080481 5060781 5092181 5103181 5122081 6022881 6051681 6062781 6081281 6092881 4121881 5051381 5080482 5062181 5092182 5110781 6010381 6030181 6051682 6062881 6081481 6092981 4122081 5051681 5080581 5062281 5100181 5110881 6010382 6030381 6051981 6062981 6081482 6100281 4122181 5051781 5080881 5062282 5100381 5110981 6010481 6030881 6052282 6070681 6081581 4122881 5020781 5080882 5062381 5100481 5111081 6010981 6030981 6052381 6070781 6081781 4122981 5020981 5080981 5062382 5100681 5111082 6011181 6031081 6052382 6070782 6082181 4123081 5021081 5081081 5062881 5100682 5111181 6011281 6031381 6052581 6071081 6082281 4123082 5021681 5081181 5071881 5101081 5111182 6011381 6031481 6052681 6071082 6082282 5010481 5021781 5082281 5071981 5101082 5111281 6011382 6032481 6053081 6071181 6082381 5010581 5022181 5082282 5071982 5101181 5111481 6011781 6032482 6053082 6071281 6082481 5010682 5022481 5032881 5082381 5101182 5111581 6011881 6032781 6053181 6071381 6082581 5011081 5022581 5033081 5082481 5101281 5111582 6012381 6032981 6060281 6071382 6082681 5011181 5022881 5033181 5082482 5101282 5111681 6012382 6040681 6060282 6071781 6082881 5011381 5030181 5040481 5082681 5101381 5111781 6012481 6041081 6060381 6071881 6082882 5011481 5030281 5040581 5082981 5101382 5112181 6012581 6041181 6060581 6071981 6082981 5011881 5030481 5040881 5083081 5101481 5112281 6012681 6041281 6060681 6072082 6083081 5011981 5030781 5041181 5090181 5101581 5112282 6012781 6041381 6060682 6072281 6090582 5012181 5031481 5041281 5090281 5101781 5112881 6013081 6041781 6060781 6072481 6090681 5012781 5031581 5041381 5090681 5101782 5112981 6020281 6041881 6060881 6072482 6090781 5020181 5031782 5041481 5090682 5101783 5112982 6020681 6042082 6060981 6072681 6090881 5020281 5031881 5041581 5090683 5101881 5113081 6020781 6042481 6061281 6072781 6091181
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed to a total of 529 consignees, 482 domestic and 47 international. Product was sent Nationwide, Europe and Asia.
  • Descripción del producto
    Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
  • Manufacturer
    Guidant Cardiac Surgery

Manufacturer

Guidant Cardiac Surgery
  • Dirección del fabricante
    Guidant Cardiac Surgery, 3200 Lakeside Dr, Santa Clara CA 95054-2807
  • Source
    USFDA