ORBIT 90 SUBCUTANEOUS INFUSION SET 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INSULINPUMPS.CA 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
    105538
  • 사례 위험등급
    I
  • 사례 시작날짜
    2011-02-16
  • 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
    All lots of triad alcohol prep pads co-packaged and distributed with icu medical orbit 90 infusion sets and orbit micro infusion sets are being recalled because of concerns about potential contamination of the triad group's product with the bacteria bacillus cereus. the infusion sets are not contaminated and may continue to be used safely.

Device

  • 모델명 / 제조번호(시리얼번호)
    10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")" v-b-tooltip> Model Catalog: M1861 M2461 M2491 M3091 (Lot serial: ">10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")
  • 제품 설명
    ORBIT 90 SUBCUTANEOUS INFUSION SET
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • Source
    HC