Events

Retiro De Equipo (Recall) de Device Recall TEG 5000

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 Haemoscope Division of Haemonetics Corp.

¿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
    57809
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1738-2011
  • Fecha de inicio del evento
    2011-01-28
  • Fecha de publicación del evento
    2011-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97481
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Causa
    Haemonetics has received a report of smoke from the unit with a power supply failure.
  • Acción
    Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.

Device

Device Recall TEG 5000
  • Modelo / Serial
    list 07-022 (TEG 5000), all serial numbers
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
  • Descripción del producto
    TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 || a multipurpose system for in vitro coagulation studies
  • Manufacturer
    Haemoscope Division of Haemonetics Corp

Manufacturer

Haemoscope Division of Haemonetics Corp
  • Dirección del fabricante
    Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
  • Empresa matriz del fabricante (2017)
    Haemonetics Corporation
  • Source
    USFDA