Events

Rappel de Hypothermia Caps, Mittens and Slippers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Control Medics 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-2018-RN-00121-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-12
  • 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-2018-RN-00121-1
  • 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
    The manufacturer, southwest technologies are recalling all hypothermia products including caps, mittens and slippers for the intended use of reduction of chemotherpay induced alopecia, onycholysis and skin toxicity. the devices are misbranded for use during chemotherapy treatments, and may lead to frostbite to digits on patients with, but not limited to diabetic neuropathy, raynaud's disease, distal metastasis, distal arteriopathy and cold intolerance. there have been reports of serious injuries overseas as a result of this issue.
  • Action
    Control Medics is advising customers to discontinue use of affected products immediately. Customers are advised to quarantine all affected stock to prevent further use and return it to Control Medics.

Device

Hypothermia Caps, Mittens and Slippers
  • Modèle / numéro de série
    Hypothermia Caps, Mittens and SlippersProduct Name: Hypothermia CapProduct Number: cap-610Batch Number: 052016C Product Name: Hypothermia SlippersProduct Number: SL3000Batch Number: 041116DProduct Name: Hypothermia MittsProduct Number: TM7008Batch Number: 042016CARTG Number: 272254 (cancelled)
  • Manufacturer
    Control Medics Pty Ltd

Manufacturer

Control Medics Pty Ltd
  • Source
    DHTGA