CUSTOM PACK WITH SOFTLINE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MAQUET-DYNAMED 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
    17225
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-08-08
  • 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
    New more stringent internal testing conducted by maquet cardiopulmonary to reduce the possibility of any quality issues in the field has indicated that specific oxygenator lots may not meet product specifications. specifically internal testing indicates that the outlet or/and inlet connector port of the unit may dislodge and separate from the main body of the oxygenator. please note that this recall pertains to specific lots of oxygenators. users need to continue to use the reusable mechanical clamp provided by maquet with all remaining maquet quadrox oxygenators currently in distribution. the specific lots within this recall may have an increased tendency for separation as indicated in the internal testing results.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: BO-HQV 46901 (Lot serial: 92087670); Model Catalog: HQV 56103 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 70091907); Model Catalog: HQV 55806 (Lot serial: 92087265); Model Catalog: HQV 56103 (Lot serial: 92087265); Model Catalog: HQV 55806 (Lot serial: 92084433); Model Catalog: HQV 56103 (Lot serial: 92084433); Model Catalog: HQV 55806 (Lot serial: 92089326); Model Catalog: HQV 56103 (Lot serial: 92088079); Model Catalog: HQV 55806 (Lot serial: 92088079); Model Catalog: HQV 56103 (Lot serial: 92089326); Model Catalog: HMO 71000 (Lot serial: 70082790); Model Catalog: HMO 70000 (Lot serial: 70082790); Model Catalog: BE-PLS 2051 (Lot serial: 70075041); Model Catalog: HMO 71000 (Lot serial: 70082328); Model Catalog: HMO 70000 (Lot serial: 70082328); Model Catalog: VKMO 70000 (Lot serial: 70081881); Model Catalog: BEQ-HQV 46900 (Lot serial: 92098557); Model Catalog: BEQ-HQV 46900 (Lot serial: 92084424); Model Catalog: BEQ-HQV 46900 (Lot serial: 92096512); Model Catalog: BEQ-HQV 46
  • 제품 설명
    CUSTOM PACK WITH SOFTLINE
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC