Events

Retiro De Equipo (Recall) de Device Recall 2.0 mL Cartridge/Syringe Piston component of Insulin Pump

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
    58047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1678-2011
  • Fecha de inicio del evento
    2011-02-25
  • Fecha de publicación del evento
    2011-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98100
  • 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
    Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.
  • Acción
    Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call 1-877-280-2339. Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.

Device

Device Recall 2.0 mL Cartridge/Syringe Piston component of Insulin Pump
  • Modelo / Serial
    Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and France.
  • Descripción del producto
    2.0 mL Cartridge/Syringe Piston component of Insulin Pump || Insulin infusion
  • Manufacturer
    Animas Corporation

Manufacturer

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