Events

Rappel de Nellcor RS10 SpO2 Forehead Sensor

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-2016-RN-01644-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-23
  • 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-2016-RN-01644-1
  • 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
    Medtronic is recalling specific item codes and production lots of the covidien nellcor rs10 spo2 forehead sensor. this recall is being conducted due to a labelling error. the label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. the sensor array itself is latex free. the use of products containing latex may result in allergic reactions for patients and providers who have latex sensitivity. allergic reactions can include skin rash, itching, dyspnoea and anaphylaxis. there have been no reports of serious injury associated with this issue.
  • Action
    Medtronic is advising users to quarantine and discontinue use of the affected item codes and lots. Also, immediately advise all surgeons/surgery personnel of this recall. Medtronic will be issuing credit for returned devices.

Device

Nellcor RS10 SpO2 Forehead Sensor
  • Modèle / numéro de série
    Nellcor RS10 SpO2 Forehead Sensor Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H, 161970090H, 162040107H, 162110103H, 162320191H and 162390212HARTG Number: 182876
  • 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