Events

Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Merck 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-2016-RN-00768-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00768-1
  • 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
    Merck has received a product complaint regarding concerns of colour indications on packaging being insufficiently clear and the possibility of end users confusing the colour coding in the explanatory box with the corresponding colour on the ph strip. please note that with these ph indicator papers, the printed scale on the packaging serves purely as an instruction on how to use the product. the ph is only identified by comparison of the test square with the printed colours on the test strip itself.
  • 조치
    Merck is advising users to inspect stock and remove any remaining strips of the affected lots from use. Affected stock will be replaced with a revised indicator strip or a credit note issued. This action has been closed-out on 20/02/2017.

Device

Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tub...
  • 모델명 / 제조번호(시리얼번호)
    Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)Catalogue number: IN01Order code: NAAUIN01Lot Numbers: 509029, 604025ARTG number: 260068
  • Manufacturer
    Merck Pty Ltd

Manufacturer

Merck Pty Ltd