Events

Hypothermia Caps, Mittens and Slippers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Control Medics Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00121-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00121-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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