Events

Retiro De Equipo (Recall) de 1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator Tapes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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-2017-RN-00635-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-05-19
  • 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-2017-RN-00635-1
  • 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
    During a recent investigation, the manufacturer confirmed some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • Acción
    3M Australia is requesting users to discontinue use of affected products and notify 3M to receive a refund or replacement. Distributors are requested to cease distribution of affected products and forward the recall notification to customers who have received the affected lots. Distributors are further requested to consolidate returned products from their customers with their own affected stock and notify 3M accordingly to receive a refund or replacement.

Device

1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes f...
  • Modelo / Serial
    1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator TapesStock Numbers: CT060934651 & CT060934669Roll Sizes: 1322-18MM & 1322-24MM (respectively)1355 3M Comply Lead Free Steam Indicator Tapes for Disposable WrapsStock Numbers: CT060934693 & CT060934701Roll Sizes: 1355-18MM & 1355-24MM (respectively)Lot No: 2018-04RA, 2018-05RB, 2018-06RC & 2018-06RD ARTG Number: 126363
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA