Events

Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml 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
    17037
  • 사례 시작날짜
    2014-07-25
  • 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
    The recall is being conducted as a precautionary measure due to out of specification results observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. coseal's failure to gel does not represent risk for the patient's life. all other stability requirements were met.
  • 조치
    Product to be returned to supplier

Device

Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml
  • 모델명 / 제조번호(시리얼번호)
    Model: Product code: 934073 (2ml) & 934074 (4ml), Affected: Selected lots
  • Manufacturer
    Baxter Healthcare Corporation SA

Manufacturer

Baxter Healthcare Corporation SA