Events

Baxter MiniCap with Povidone-Iodine Solution 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Baxter Healthcare Corporation SA 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
    18002
  • 사례 시작날짜
    2015-02-11
  • 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
    Baxter received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing. use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the transfer when the transfer set is not connected to the patient line of the automated peritoneal dialysis (apd) cassette or continuous ambulatory peritoneal dialysis (capd) twin bag set-ups. this may increase the risk of peritonitis.
  • 조치
    Manufacturer to issue advice regarding use

Device

Baxter MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Corporation SA