Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Multigate Medical Products 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
    RC-2015-RN-00601-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-02
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Convatec is conducting a recall (tga ref no: rc-2015-rn-00514-1) of various sized unomedical branded suction tubes. the tubes are being recalled as the connector on the tubes has a probability of cracking once it is applied to suction device ports.Multigate is issuing this notice to your hospital as you have received the above custom procedure packs (cpp) where you have specified the inclusion of the unomedical suction tube that is now subject to this recall.
  • 조치
    Multigate requesting end users to stop using the affected CPP. Multigate will supply replacement sterile tubing as for all the affected stock. Once replacement tubing is received end users are required to replace the defective tube with the sterile replacement product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube
  • Manufacturer

Manufacturer