Events

Retiro De Equipo (Recall) de Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector

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
    34598
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0586-06
  • Fecha de inicio del evento
    2006-02-06
  • Fecha de publicación del evento
    2006-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44161
  • 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
    Container, I.V. - Product Code KPE
  • Causa
    B. braun medical has been notified by the manufacturer of the product (stedim) that a small percentage of the lots leak from the set port when the set port is opened. the leak was identified by stedim to be due to the incorrect placement of a septum in the set port. the set closure is intact and the leak remains internal until the set port is opened.
  • Acción
    A recall notification letter was sent to the 22 customers who received the product between 12/1/05 and 1/11/06. The recall packages included a letter addressed to either the Director of Pharmacy/Director of Nursing, Materials Manager, or Distributor, as appropriate. They were mailed via US Post Office certified return receipt mail. Customers were instructed by letter to return all product at their facility to B. Braun Medical, Inc. in Breinigsville Pennsylvania. A Recall Information Form and a postage paid B. Braun Medical, Inc. return envelope were included in the recall package for the customer''s use.

Device

Device Recall B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector
  • Modelo / Serial
    Lot Numbers: 05A14474, 05A18561, & 05A19926
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide to: CA, CT, FL, GA, KS, MD, MI, NC, NJ, NY, SC, TN, & TX
  • Descripción del producto
    B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
  • Manufacturer
    B. Braun Medical Inc

Manufacturer

B. Braun Medical Inc
  • Dirección del fabricante
    B. Braun Medical Inc, 2525 McGaw Ave, Irvine CA 92614-5841
  • Source
    USFDA