Retiro De Equipo (Recall) de Hypochlorite 1% Solution & Hypochlor 1% Solution

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Dentalife Australia 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-01222-2
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-12-15
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    It has come to dentalife's attention that there is a contamination risk in two batches of sodium hypochlorite solution small particles of black matter have been observed floating in several 1.25l bottles of the solution. the issue has been investigated and the material is suspected to be particles of a food grade grease used to lubricate the volumetric filling device as part of the manufacturing process.
  • Acción
    Dentalife is advising users to discard affected stock for replacement. This action has been closed-out on 29/08/2016.

Device

  • Modelo / Serial
    Hypochlorite 1% Solution & Hypochlor 1% SolutionProduct Codes: DL0403, HPH125 (1.25L) and DL0401 (500mL)Batch Numbers: 2356 and 4209Expiry Dates: 06/17 and 09/17ARTG Number: 160242
  • Manufacturer

Manufacturer