Events

Baxter Colied Tube INFUSOR System cs 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Baxter Healthcare Corporation 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
    16553
  • 사례 시작날짜
    2014-04-17
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • 원인
    Manufacturer has received complaints for infusion flow rates greater than intended for the listed portable elastomeric infusion systems. manufacturer is requesting that healtrhcare providers consider the instructions for use which explain facts that may impact resulting flow rate., point #5 of the instructions for use is incorrect and manufactrer will be making a change to this to reflect this information.
  • 조치
    Instructions for use to be updated

Device

Baxter Colied Tube INFUSOR System cs
  • 모델명 / 제조번호(시리얼번호)
    Model: 2C1071KJP 1C1071KJ 1C1073KJP 2C1075KJP 2C1080KJP 2C1082KJP and 2C1082KJ, Affected:
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation