Events

Retiro De Equipo (Recall) de Device Recall Chiba Needle Marked

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 Remington Medical Inc..

¿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
    52781
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1935-2009
  • Fecha de inicio del evento
    2009-06-19
  • Fecha de publicación del evento
    2009-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83992
  • 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
  • Causa
    Two unsealed pouches were identified after product release, compromising product sterility.
  • Acción
    Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.

Device

Device Recall Chiba Needle Marked
  • Modelo / Serial
    Lot number 091386.
  • Distribución
    US - CA and WI.
  • Descripción del producto
    Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. || General purpose aspiration Cytology Biopsy Needle
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Dirección del fabricante
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Empresa matriz del fabricante (2017)
    Remington Medical, Inc.
  • Source
    USFDA