Events

Retiro De Equipo (Recall) de Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits

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

¿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-01060-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-15
  • 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-01060-1
  • 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 regular qa inspection, the manufacturer mediplas identified an irregularity in the expandable tubing of specific batches of disposable expandable adult 22mmid expandable anaesthetic circuits. due to this, all remaining unused circuits from the affected batches will be replaced with unaffected product without any additional cost to the customer.
  • Acción
    Parker Healthcare is requesting that customers: 1. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact the Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. 2. Complete the Facsimile/Email Reply Form supplied with the customer letter within 5 business days, even if you no longer have affected product, as this information is required to reconcile this process. If any of the recalled products have been transferred to another facility, please immediately let them know of this Recall, and record it on the Facsimile/Email Reply Form.

Device

Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits
  • Modelo / Serial
    Disposable Expandable Adult 22mmID Expandable Anaesthetic CircuitsPart Numbers:A3E120-700 - 120"/3m Length with Swivel Y AdaptorA3E120-102 - 120"/3m Length with Fixed Y Adaptor and Mask ElbowA3E120-100 - 120"/3m Length with Fixed Y Adaptor A3E240-700 - 240"/6m Length with Swivel Y Adaptor A3E120-702 - 120"/3m Length with Swivel Y Adaptor and Mask ElbowMultiple Batch/Lot NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA