Events

Retiro De Equipo (Recall) de Device Recall Sterile IV Start Kit

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
    75291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0691-2017
  • Fecha de inicio del evento
    2016-07-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149990
  • 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
    I.V. start kit - Product Code LRS
  • Causa
    Positive results from non-routine sterility testing commissioned by b. braun medical inc. (bbmi) for the finished product of this lot.
  • Acción
    BBMI (B. Braun) provided written notification on August 05, 2016, to all BBMI customers in receipt of the suspected product. These customers included both BBMI direct end customers and BBMI direct distributors. Customers were asked to determine if they had the affected lots in their possession. If they did, customers were asked not to destroy the product and to immediately discontinue use of and quarantine if found. Customers were also asked to complete the Product Removal Acknowledgement form and return to B. Braun. B. Braun will contact each customer if they have any full cases, partial cases or unused pieces of the affected products to provide instructions for handling and return of the affected products. Customers with questions were instructed to call 1-800-227-2862.

Device

Device Recall Sterile IV Start Kit
  • Modelo / Serial
    Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to GA, IL, and FL
  • Descripción del producto
    Sterile IV Start Kits || 50 units/trays per case || Convenience kit for IV start procedures
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

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