Events

Retiro De Equipo (Recall) de Device Recall Onpharma

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 Valeant Pharmacueticals International.

¿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
    73678
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1699-2016
  • Fecha de inicio del evento
    2016-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144726
  • 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
    unknown device name - Product Code N/A
  • Causa
    It has been determined that the onset mixing pen has an optimal use period of 18 months from start of use. however, the current labeling and ifu does not stipulate this time period.
  • Acción
    Valeant sent a letter entitled "Field Correction to Orapharma Onset Mixing Pen," dated 1/29/2016, to customers via UPS. The letter identified the affected device and the issue involved. The firm recommends that users stop using the device if it had been in use for more than 18 months. Customers were to refer to the list of the affected lots to determine if their device needed to be replaced. If the device was one of the ones identified, users were to contact Valeant Pharmaceuticals to arrange for a replacement at no charge. Questions should be directed to customer service 800-321-4576.

Device

Device Recall Onpharma
  • Modelo / Serial
    Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. || Manufactured for Onpharma Inc. Los Gratos, CA 95030 || The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
  • Manufacturer
    Valeant Pharmacueticals International

Manufacturer

Valeant Pharmacueticals International
  • Dirección del fabricante
    Valeant Pharmacueticals International, 400 Somerset Corporate Blvd, Bridgewater NJ 08807-2867
  • Source
    USFDA