Events

Retiro De Equipo (Recall) de Via2BagDirect Connect

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 Medimop Medical Projects Ltd..

¿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
    79243
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0972-2018
  • Fecha de inicio del evento
    2017-10-06
  • 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=161741
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Causa
    Medimop is recalling certain lots of this product vial2bag dc due to the potential of the iv port separating from the via12bag dc body during the drug reconstitution i iv set attachment process.
  • Acción
    The recalling firm's sent an Urgent Medical Device Recall Letter dated October 13, 2017. was supplied to the consignee which contains the instructions for the recall process to the consignee. The notification letter will be sent to the Distributor via email. The notification letter instructs the distributor to notify the Customer/Users via the Medimop consignee recall letter. For further questions, please call (610) 594-4353.

Device

Via2BagDirect Connect
  • Modelo / Serial
    Lots: 9507,9508,9509,9510,9511,9512,9513.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution
  • Descripción del producto
    Vial2BagDC, Product Number 6070112. || The 20mm Vial2Bag DC device, is intended for use in || healthcare facilities or in-home environment by the patient || or care-giver to aid and support prescribed treatment and || therapy. The device consists of the Vial2Bag piercing || spike and cover, the IV Port connector and an integrated || Vial Adapter (20mm) for access to the drug/solution vial.
  • Manufacturer
    Medimop Medical Projects Ltd.

Manufacturer

Medimop Medical Projects Ltd.
  • Dirección del fabricante
    Medimop Medical Projects Ltd., 4 Hayetzira Street,, P.O. Box 2499, Raanana Israel
  • Source
    USFDA