MEDICATION CASSETTE RESERVOIR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SMITHS MEDICAL CANADA LTD. (SIMS) 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
    44005
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-02-03
  • 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
    Smiths medical has received a small number of complaints of leakage in some cadd medication cassette reservoirs 50ml. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if noticed during cassette filling it could result in a delay of therapy while an alternative cassette is obtained. if noticed during fluid delivery with the patient it could result in an interruption in therapy while the cassette is replaced. smiths medical has received no reports of serious injury or death related to this issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 21-7001-24 (Lot serial: 14X-297); Model Catalog: 21-7301-24 (Lot serial: 14X-297); Model Catalog: 21-7001-24 (Lot serial: 14X-323); Model Catalog: 21-7301-24 (Lot serial: 14X-323); Model Catalog: 21-7001-24 (Lot serial: 14X-324); Model Catalog: 21-7301-24 (Lot serial: 14X-324)
  • 제품 설명
    CADD MEDICATION CASSETTE RESERVOIR50ML
  • Manufacturer

Manufacturer