Events

Rappel de Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule

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

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-2014-RN-01130-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • 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-2014-RN-01130-1
  • 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
    Covidien pty ltd (covidien), following advice from the therapeutic goods administration and the manufacturer marck biosciences ltd (now known as amanta healthcare ltd) that batch number 1t2324002 of the below product has failed the test for sterility, is recalling this batch at the retail level. please note that there have been no adverse events reported regarding this sterility test failure.
  • Action
    Covidien is requesting the customers to identify and quarantine the affected stock. Covidien will arrange for shipment pickup from the distribution centre and will provide credit note for the returned stock. This action has been closed-out on 05/12/2016.

Device

Gelflex Sterile Eye Wash Normal Saline 10mL Ampoule
  • Modèle / numéro de série
    Gelflex Sterile Eye Wash Normal Saline 10mL AmpouleProduct code: 8200Batch number: 1T2324002Expiry Date: December 2017ARTG Number: 151536
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA