Events

Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medline International Two 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
    RC-2015-RN-00606-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00606-1
  • 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
    An internal assessment of convatec’s product complaints has confirmed that these devices are not meeting their expectations or those of our customers. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. suction tubes are intended to connect a suction device, such as a suction catheter or suction handle, to a vacuum unit. suction tubes are equipped with multi-purpose connectors that are designed to fit many suction devices and outlets. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • 조치
    Medline is requesting end users to remove and discard the Unomedical Suction Tubing from the procedure pack at the time the scrub nurse prepares for the surgery. This action has been closed-out on 15/08/2016.

Device

Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile)
  • 모델명 / 제조번호(시리얼번호)
    Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile) Sterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 137961 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd