Events

Medline Custom Procedure Kit, incorporating Unomedical suction tubing 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medline Assembly Australia Pty Ltd 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
    18830
  • 사례 시작날짜
    2015-07-08
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • 원인
    Medline is recalling specified lots of the unomedical suction tubing. this tubing is a component in the medline procedure pack product code sotnzah04b., an internal assessment of convatec's product complaints confirmed that these devices were not meeting customer expectations. the connector parts for application to the suction device in these lots have failed to meet their required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction device outlets. cracking may result in loss of suction during an operation. this could result in reduced surgical site visibility (due to poor removal of fluid) and may make stemming of bleeding more difficult.
  • 조치
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kit, incorporating Unomedical suction tubing
  • 모델명 / 제조번호(시리얼번호)
    Model: SOTNZAH04B, Affected: CS1405587, CS1417569, CS1418438, CS1418710, CS1419278, CS1420864, CS1422092, CS1423500, CS1423501, CS1423955, CS1527665, CS1528112, CS1528978, CS1529680, CS1529789, CS1531866
  • Manufacturer
    Medline Assembly Australia Pty Ltd

Manufacturer

Medline Assembly Australia Pty Ltd