Events

Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal mask airway 2 Large paediatric, wire-reinforced laryngeal mask airway 2.5 Small adult, wire-reinforced laryngeal mask airway 3 Medium adult, wire-reinforced laryngeal mask airway 4 Large adult, wire-reinforced laryngeal mask airway 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Intersurgical Australia 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-2017-RN-00447-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00447-1
  • 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
    An internal assessment by intersurgical of product performance, including a review of customer complaints, has confirmed that specific solus flexible wire-reinforced laryngeal mask airway products have a manufacturing fault in the tube. this fault can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
  • 조치
    Intersurgical is advising users to inspect their stocks and quarantine all units from the affected lot numbers, and to destroy these affected products. Credit will be arranged for this stock.

Device

Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal...
  • 모델명 / 제조번호(시리얼번호)
    Solus Flexible, wire-reinforced laryngeal mask airwaySmall paediatric, wire-reinforced laryngeal mask airway 2Large paediatric, wire-reinforced laryngeal mask airway 2.5Small adult, wire-reinforced laryngeal mask airway 3Medium adult, wire-reinforced laryngeal mask airway 4Large adult, wire-reinforced laryngeal mask airway 5Order Codes: 8002001, 8025001, 8003001, 8004001, 8005001Lot Numbers: from 31310354 to 31700331ARTG Number: 224554
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd