Events

Retiro De Equipo (Recall) de Device Recall Halo Closed System Transfer Device

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 J&J; Solutions, Inc. DBA Corvida Medical.

¿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
    75810
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1003-2017
  • Fecha de inicio del evento
    2016-11-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151346
  • 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
    Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
  • Causa
    Product malfunction: needle does not retract.
  • Acción
    Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.

Device

Device Recall Halo Closed System Transfer Device
  • Modelo / Serial
    Lot 0610525, 2017-10-18
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
  • Descripción del producto
    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
  • Manufacturer
    J&J; Solutions, Inc. DBA Corvida Medical

Manufacturer

J&J; Solutions, Inc. DBA Corvida Medical
  • Dirección del fabricante
    J&J; Solutions, Inc. DBA Corvida Medical, 2261 Crosspark Rd Ste 127, Coralville IA 52241-4716
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA