RING AND TANDEM COMBO KIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 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
    82186
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-10-01
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    An anomaly has been identified with the al07289000 rectal retractor stainless steel. the rectal retractors have shown evidence that contaminates or fluids may enter into the center of the rectal retractor paddle through the cross pins or bottom rod areas. the rectal retractor instruments have been identified to potentially have contaminating materials present after clinical use that cannot be removed by the instructed cleaning disinfecting and sterilization method. at this time it appears that the design of the paddle component is allowing for ingress and retention of bodily fluids or cleaning reagents during their clinical use and during their reprocessing for re-use. this issue is an internal finding - therefore no misadministration or serious deterioration in the state of health was reported. there have been no reports of this issue that have occurred in canada or within the eea member states.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: AL13016002 (Lot serial: H600346); Model Catalog: AL13015000 (Lot serial: H600346); Model Catalog: AL13016000 (Lot serial: H600346); Model Catalog: AL13016001 (Lot serial: H600346)
  • 제품 설명
    Ring and Tandem Combo Kit
  • Manufacturer

Manufacturer