Events

Rappel de Disposable Expandable Adult 22mm ID Expandable Anaesthetic Circuits

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Swirl Technologies Pty Ltd T/A Parker Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01060-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01060-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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