Events

Retiro De Equipo (Recall) de Device Recall Esmark Elastic Bandage, 3" x 4 yards

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 Cardinal Health.

¿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
    50198
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0615-2009
  • Fecha de inicio del evento
    2008-11-18
  • Fecha de publicación del evento
    2009-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74940
  • 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
    Bandage, elastic - Product Code FQM
  • Causa
    The natural rubber latex bandages were mislabeled as latex free.
  • Acción
    A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.

Device

Device Recall Esmark Elastic Bandage, 3" x 4 yards
  • Modelo / Serial
    Catalog number 23580-034: Work order numbers 304696 and 312977.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA, Guam and Korea.
  • Descripción del producto
    Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787. || The device is used to promote blood flow from the extremities by compressing the superficial vessels.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Dirección del fabricante
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA