Events

Retiro De Equipo (Recall) de Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)

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

¿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-2016-RN-01226-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-13
  • 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-2016-RN-01226-1
  • 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
    Honeywell is recalling a single lot of 32oz eyesaline eyewash solution because of reports of possible contamination with klebsiella pneumoniae. there could be an increased health risk of eye infections, and infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. there have been no reports of injury.
  • Acción
    Consumers are being contacted by retailers who have been supplied with the product by Honeywell. This action has been closed-out on 09/06/2017

Device

Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)
  • Modelo / Serial
    Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)Lot Number: F16091-61
  • Manufacturer
    Honeywell Safety Products

Manufacturer

Honeywell Safety Products