Events

Retiro De Equipo (Recall) de CROSSOVER Sheath 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 Cordis Corporation.

¿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
    53574
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0087-2010
  • Fecha de inicio del evento
    2009-10-15
  • Fecha de publicación del evento
    2009-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85892
  • 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
    Cordis has received complaints of stretching or fracture of the sheath shaft during use.
  • Acción
    A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers. A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460). In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.

Device

CROSSOVER Sheath Introducer
  • Modelo / Serial
    Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047;  Catalog Number: 403585S, Lot Number U0000025;  Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052;  Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050;  Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and  Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
  • Descripción del producto
    Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. || Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA || Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. || The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Dirección del fabricante
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA