ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE 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
    74016
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-03-02
  • 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
    The manufacturer has determined that listed products may possess levels of endotoxin that exceed regulatory limits. mcp has become aware that its sampling plans for endotoxin testing on products labeled "non-pyrogenic" were not compliant with usp requirements for endotoxin on medical devices and ansi/aami st72: 2011 bacterial endotoxins - test methods routine monitoring and alternatives to batch testing. while maquet has not received any complaints of adverse events related to endotoxin exposure maquet cannot ensure devices labeled "non-pyrogenic" are without endotoxin based on a statistically valid sampling plan.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: BEQ-RF-32 (Lot serial: all lots); Model Catalog: BO-S 2565 (Lot serial: all lots); Model Catalog: BO-S 2564 (Lot serial: all lots); Model Catalog: VKMO 31000 (Lot serial: all lots); Model Catalog: VKMO 30000 (Lot serial: all lots); Model Catalog: BO-VKMO 31000 (Lot serial: all lots); Model Catalog: BO-HQV 104802 (Lot serial: all lots); Model Catalog: BO-HQV 104100 (Lot serial: all lots); Model Catalog: BO-H 104801 (Lot serial: all lots); Model Catalog: BO-H 101111 (Lot serial: all lots); Model Catalog: BO-H65000 (Lot serial: all lots); Model Catalog: RF-32 (Lot serial: all lots); Model Catalog: BEQ-RF-32(USA) (Lot serial: all lots); Model Catalog: BEQ-H 84702 (Lot serial: all lots); Model Catalog: BEQ-H 66607 (Lot serial: all lots); Model Catalog: BEQ-H 66603 (Lot serial: all lots); Model Catalog: BEQ-H 59210 (Lot serial: all lots); Model Catalog: BEQ-H 59209 (Lot serial: all lots); Model Catalog: BEQ-H 56100 (Lot serial: all lots); Model Catalog: BEQ-H 55105 (Lot serial: all lots); Model Cata
  • 제품 설명
    ROTAFLOW CENTRIFUGAL PUMP WITH BIOLINE;CIRCULATORY CIRCUIT SOFTLINE;QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR;PERFUSION SET WITH SOFTLINE COATING;SMALL ADULT HEART LUNG PERFUSION PACK WITH SOFTLINE COATING;ROTAFLOW CENTRIFUGAL PUM
  • Manufacturer

Manufacturer

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