Events

Retiro De Equipo (Recall) de Device Recall ET20 Anesthesia Extension Tubes

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 Global Healthcare Inc.

¿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
    73046
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0696-2016
  • Fecha de inicio del evento
    2016-01-06
  • Fecha de publicación del evento
    2016-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142907
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
  • Acción
    Global Healthcare sent an "Urgent: DEVICE RECALL" letter dated January 6, 2015 to its Customer by email. The letter described the product, problem and actions to be taken. The customer was instructed to immediately examine its inventory to determine if you have any of the Model ET-20 on hand; if so, immediately discontinue distributing product; and complete and return the Distributor Device Recall Response Form by email. Additionally, if you have further distributed any of the product, immediately contact your accounts; advise them of recall situation and have them return their outstanding recalled stocks to you. Any returned product will be destroyed by the distributor upon receipt of all affected product. If you require further assistance, please call 770-522-7520.

Device

Device Recall ET20 Anesthesia Extension Tubes
  • Modelo / Serial
    Lot Number 1505201
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to state of: GA only.
  • Descripción del producto
    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
  • Manufacturer
    Global Healthcare Inc

Manufacturer

Global Healthcare Inc
  • Dirección del fabricante
    Global Healthcare Inc, 11350 Old Roswell Rd, Suite 700, Alpharetta GA 30009-2291
  • Source
    USFDA