Events

Retiro De Equipo (Recall) de Device Recall Cardinal Health Tiny Toes

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 Philips Electronics North America 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
    72681
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0543-2016
  • Fecha de inicio del evento
    2015-11-20
  • Fecha de publicación del evento
    2015-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141972
  • 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
    Pack, hot or cold, disposable - Product Code IMD
  • Causa
    Heel warmers may cause first and second degree burns.
  • Acción
    Cardial Health was notified of the recall via letter on 11/20/2015. Cardinal Health notified all of their customers as of 12/1/2015. Philips instructed Cardinal Health do take the following steps: 1.) Check for and destroy any inventory of Cardinal Health Tiny Toes. 2.) Complete the Distributor Reply Form included in this letter to document this action. Fax to Philips Healthcare at +1 404-855-4900. Please do not return any product to Philips. 3.) Determine which of your customers may have affected product. 4.) Ask your customers to follow the instructions in the section entitled: ACTIONS FOR CARDINAL HEALTH CUSTOMERS/USERS TO TAKE. 5.) As you receive signed Customer Reply Forms from your customers, please forward a running monthly summary to us. Please email the summary to Jennifer Maglio at jennifer.maglio@philips.com. To maintain complete documentation, please retain your customers completed reply forms. Philips may request access to particular reply forms to respond to an audit inquiry. Actions for Cardinal Health Customers to Take: 1.) Discontinue use of Cardinal Health Tiny Toes. 2.) Check for any inventory of Cardinal Health Tiny Toes. 3.) Destroy all products on hand (eg. by activating or puncturing each unit). 4.) Complete and sign the Customer Reply Form provided in this letter or Cardinal Healths version thereof, to notify Cardinal Health of how many Cardinal Health Tiny Toes were destroyed. Submit your signed reply form only after you have completed all steps

Device

Device Recall Cardinal Health Tiny Toes

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA