PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT 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
    33305
  • 사례 위험등급
    II
  • 사례 시작날짜
    2005-05-24
  • 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
    Guiding catheters which have been discovered to have weakened sidewalls in the area around the black over molded "stop" which may compromise the devices resistance to breakage. the "stop" may become detached.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 538090E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K518075 K520177 K548751); Model Catalog: 538080E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K510893); Model Catalog: 538090E (Lot serial: K510891 K510892 K565595); Model Catalog: 538080E (Lot serial: K510891 K510892 K565595); Model Catalog: 538070E (Lot serial: K510891 K510892 K565595); Model Catalog: 538090E (Lot serial: K586109 K614402 K629274); Model Catalog: 538080E (Lot serial: K586109 K614402 K629274); Model Catalog: 538070E (Lot serial: K586109 K614402 K629274); Model Catalog: 538090E (Lot serial: K515076 K518078 K558496); Model Catalog: 538080E (Lot serial: K515076 K518078 K558496); Model Catalog: 538070E (Lot serial: K515076 K518078 K558496); Model Catalog: 538090E (Lot serial: K559483 K614996 K630177); Model Catalog: 538080E (Lot serial: K559483 K614996 K630177); Model Catalog: 538070E (Lot serial: K559483 K614996 K630177); Model Catalog: 538090E (Lot serial: K523556 K527903 K548745); Model Catalog: 53
  • 제품 설명
    portex perfit percutaneous dilational
  • Manufacturer

Manufacturer