Events

AMS AdVance XP Male Sling System - Needle passers 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 American Medical Systems 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
    17127
  • 사례 시작날짜
    2014-08-06
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 원인
    As a result of routine periodic product shelf life testing, manufacturer has identified that the sterile barrier of some samples of packaging of the needle passer components supplied with the advance® xp male sling system, may have potentially been breached and therefore do not consistently meet the three (3) year shelf life stated on the product label. further testing confirms that the packaging of the needle passers continues to meet the requirements for the one (1) year shelf life., during implant procedures of the advance® xp male sling system, the two needle passers (left and right sides), are used by the surgeon to assist transobturator passage while the placing and positioning the sling. these tools are disposable and indicated for one-time-use only. there is a potential for an increased risk of patient infection due to breach in the sterile barrier (packaging) of the needle passer components.
  • 조치
    Product to be returned to supplier

Device

AMS AdVance XP Male Sling System - Needle passers

Manufacturer

American Medical Systems Inc
  • Source
    NZMMDSA