Events

Retiro De Equipo (Recall) de Device Recall Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Val

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
    51869
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1428-2009
  • Fecha de inicio del evento
    2009-03-27
  • Fecha de publicación del evento
    2009-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81481
  • 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
    Intravascular administration set - Product Code FPA
  • Causa
    Device defect is occlusion/no flow.
  • Acción
    An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.

Device

Device Recall Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure...
  • Modelo / Serial
    Lot #'s 61040841 (exp 2/28/2012) and 61040842 (exp 1/31/2012).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Canada.
  • Descripción del producto
    Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. || For use with the Horizon NXT Pump, and OutLook Safety Infusion 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