Events

Retiro De Equipo (Recall) de Device Recall CareFusion, SnowdenPencer, DiamondFlex

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 Carefusion 2200 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
    74465
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2212-2016
  • Fecha de inicio del evento
    2016-07-01
  • Fecha de publicación del evento
    2016-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147639
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Bd, formerly carefusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. if this failure were to occur while in use in a procedure it has the potential to damages tissue or organs.
  • Acción
    BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.

Device

Device Recall CareFusion, SnowdenPencer, DiamondFlex
  • Modelo / Serial
    Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
  • Descripción del producto
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. || Designed to retract or elevate organs and tissue to provide better visualization access.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Dirección del fabricante
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA