Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific 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-00755-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-26
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Convatec has received multiple reports of tubing detaching from the oxygen masks either prior to use (in the packaging) or during use. the detachment of the tubing would result in loss of oxygen to the patient. an investigation determined the failure was caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector.
  • 조치
    Thermo Fisher is advising users to inspect their stocks and quarantine all units from the affected batch numbers. Thermo Fisher will arrange for stock to be recovered and replacement stock, or a credit note, to be issued.

Device

  • 모델명 / 제조번호(시리얼번호)
    Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med ConcentrationCatalogue Numbers: PMD06001, PMD06002, PMD06003, PMD06009 and PMD06106Lot Numbers: 100914, 100551, 100550, 100574 and 100581ARTG Number: 216605
  • Manufacturer

Manufacturer