Events

Arrow Multi-Lumen Central Venous Catheters 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Arrow International 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
    16809
  • 사례 시작날짜
    2014-07-07
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • 원인
    Arrow international, inc. ("arrow") is notifying customers that there is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvcs). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. the misprint does not impact the use of the product including use of individual lumens for infusion, blood draws, etc. the colour coding of all hubs is correct and corresponds to the arrow system: white = proximal lumen; grey = medial lumen 1; blue = medial lumen 2; brown = distal lumen.
  • 조치
    Manufacturer to issue advice regarding use

Device

Arrow Multi-Lumen Central Venous Catheters
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: CS-22854-E, CS-12854-E, CS-15854-E, CS-25854-E,CS-42854-E,ASK-22854-IM, Affected: Various
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc