Events

Retiro De Equipo (Recall) de Device Recall AMS636, 60" Microbore extension set.

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 Vygon MFG, Inc., dba/ Churchill Medical Systems, 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
    76607
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1484-2017
  • Fecha de inicio del evento
    2017-02-20
  • 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=153644
  • 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, administration, intravascular - Product Code FPA
  • Causa
    Incorrect priming volume printed on the device package.
  • Acción
    Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at customerservice@vygonus.com.

Device

Device Recall AMS636, 60" Microbore extension set.

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
  • Dirección del fabricante
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., 87 Venture Dr, Dover NH 03820-5914
  • Empresa matriz del fabricante (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA