Events

Retiro De Equipo (Recall) de Device Recall Animas IR 1250 (1200 plus)

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 Animas 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
    55478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2397-2010
  • Fecha de inicio del evento
    2010-03-18
  • Fecha de publicación del evento
    2010-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90952
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Causa
    Sensor could be damaged.
  • Acción
    An Email was sent by the firm, Animas, to US patients and health care providers where email addresses were on file. Animas sent two "URGENT: MEDICAL DEVICE CORRECTION " letters one dated March 18, 2010, to all US customers, HCPs and distributors of One Touch Ping Glucose Management System and the Animas 2020 Insulin Infusion Pump and the other letter to all US patients, HCPs and distributors of Animas 2020 Insulin Infusion Pump, Animas IR 1200 and Animas IR 1250 (1200 plus). Animas also notified all global distributors and affiliates and sent the letter to customers and health care professional in those regions. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow their User Guide instructions; Pay attention to all pump warnings; NEVER rewind the pump motor, load the insulin cartridge, or prime their infusion set while connected, and fill out the enclosed reply card and send it back to Animas as soon as possible. Should you have any questions or concerns, please call the Animas Customer Support Department at 1-866-949-1525 or call toll free number on back of pump at 1-877-937-7867. If you are traveling outside of the U.S., please call 610-644-8990 and press option 1.

Device

Device Recall Animas IR 1250 (1200 plus)
  • Modelo / Serial
    Serial numbers - see word document in supporting info
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
  • Descripción del producto
    Animas IR 1250 (1200 plus) || Intended use:deliver insulin therapy
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Dirección del fabricante
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA