Events

Retiro De Equipo (Recall) de Actifuse ABX and Actifuse MIS System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty Ltd.

¿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
    RC-2015-RN-00774-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00774-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Baxter healthcare is issuing a recall of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria. in surgical procedures where there is device contact with the cerebrospinal fluid through a dural opening (iatrogenic injury), the use of a medical device with increased endotoxin levels may augment the typical inflammatory reaction to surgery and contribute to adverse health consequences. baxter has not received product-related adverse event reports that can be linked to cerebrospinal fluid exposure to increased levels of endotoxins.
  • Acción
    Users are asked to inspect their stock and to remove affected product from their facility and to contact Baxter Customer service to arrange replacements. This action has been closed-out on 05/09/2016.

Device

Actifuse ABX and Actifuse MIS System
  • Modelo / Serial
    Actifuse ABX and Actifuse MIS SystemProduct Codes: 506005078047 Actifuse ABX, 1-2 mm, 2.5 mL506005078048 Actifuse ABX, 1-2 mm, 5.0 mL506005078049 Actifuse ABX, 1-2 mm, 10.0 mL506005078057 Actifuse ABX, 1-2 mm, 20.0 mL,506005078059 Actifuse ABX, 1-2 mm, 1.5 mL506005078069 Actifuse MIS System, 1-2 mm, 7.5 mL506005078071 Actifuse MIS System Refill, 1-2 mm, 7.5 mLLot Numbers: ALLARTG Numbers: 188736 & 193684
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd