Events

Retiro De Equipo (Recall) de B. Braun Introcan Safety IV Catheter

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 B. Braun 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
    66535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0559-2014
  • Fecha de publicación del evento
    2013-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122558
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    One lot of introcan safety iv catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
  • Acción
    B. Braun sent an Urgent Medical Device Recall Notification letter dated September 27, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to utilize the attached "Product Removal Acknowledgement Form" to record the number of individual units in their inventory and fax the completed form to 610-848-1197. To ensure proper credit for affected product, customers were instructed to return the product to B. Braun Medical Inc. For questions contact Customer Support Department at 800-227-2862.

Device

B. Braun Introcan Safety IV Catheter
  • Modelo / Serial
    lot no. 3C30258317
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including Puerto Rico.
  • Descripción del producto
    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. || Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Dirección del fabricante
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA