Events

Retiro De Equipo (Recall) de Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG number: 150016Z Hyalin Plus Multipack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss 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-2013-RN-00166-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-22
  • 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-2013-RN-00166-1
  • 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
    The manufacturer has determined a potential issue relating to the sterile integrity of the pouches contained in the z hyalin multipack and z hyalin plus multipack. the content of the syringe has not been compromised, however the seal of the pouch for each individual syringe may not be adequate and sterility of the outer surface of the syringe could be compromised.This recall action was undertaken prior to notification to the tga.
  • Acción
    Affected batches should be identified and immediately returned to Carl Zeiss Pty Ltd. All lot numbers should be examined for package inegrity prior to use, as stated in the instructions for use.

Device

Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG n...
  • Modelo / Serial
    Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG number: 150016Z Hyalin Plus MultipackLot numbers: 2218AA, 2218AB. 2228AA, 2194AA, 2192APARTG number: 150017
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd