Events

SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065Lot Number: 12I20Holder, 23g X 19cm, Sterile Single PackItem Code: 450086Lot Number: 12H26Luer Adaptor, 21gx30cm, Sterile Single PackItem Code: 450095Lot Number: 12I22Luer Adaptor, 25gx30cm, Sterile Single PackItem Code: 450099Lot Number: 12H26Luer Adaptor, 23gx30cm, Sterile Single PackItem Code: 450159Lot Number: 12I14ARTG number: 150062 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Interpath Services 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-2013-RN-00290-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00290-1
  • 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, greiner bio-one, has advised that safety blood collection sets may have a small crack in the luer connector. this may cause minor leakage (small droplets) of blood or infusion liquid at the luer connector side. additionally evacuated blood collection tubes would only fill with a few droplets or would not fill at all.
  • 조치
    Interpath is recalling affected units and replacing them with unaffected stock.

Device

SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065L...
  • 모델명 / 제조번호(시리얼번호)
    SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065Lot Number: 12I20Holder, 23g X 19cm, Sterile Single PackItem Code: 450086Lot Number: 12H26Luer Adaptor, 21gx30cm, Sterile Single PackItem Code: 450095Lot Number: 12I22Luer Adaptor, 25gx30cm, Sterile Single PackItem Code: 450099Lot Number: 12H26Luer Adaptor, 23gx30cm, Sterile Single PackItem Code: 450159Lot Number: 12I14ARTG number: 150062
  • Manufacturer
    Interpath Services Pty Ltd

Manufacturer

Interpath Services Pty Ltd