Events

Retiro De Equipo (Recall) de AccuSure U100 29 Gauge, 1cc

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 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals.

¿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
    53709
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0572-2010
  • Fecha de inicio del evento
    2009-10-27
  • Fecha de publicación del evento
    2009-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86396
  • 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
    Insulin Syringe - Product Code FMF
  • Causa
    Needles are becoming dislodged from the barrels.
  • Acción
    The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure ¿¿ Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.

Device

AccuSure U100 29 Gauge, 1cc

Manufacturer

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
  • Dirección del fabricante
    Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, 120 Vintage Dr NE, Huntsville AL 35811-8216
  • Empresa matriz del fabricante (2017)
    Endo International plc
  • Source
    USFDA