Events

AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex Medical 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-00138-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00138-1
  • 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
    Teleflex medical is recalling the products listed due to a possibility that the packages may contain foreign material, (predominantly synthetically derived pvc). this foreign matter has only been found in the package and not in the gas flow path of the humidifier product. if the foreign matter particles migrate into the sterile water reservoir, or enter the connecting tubing between the reservoir and the patient, the particle could potentially enter the patient airway at very high gas flows and could cause the hazard of mild lung discomfort, which is usually temporary and reversible.
  • 조치
    A Teleflex representative will contact hospitals and medical centres to arrange for the affected devices to be inspected. Any units with foreign material will be recalled. If there is no visible foreign matter the product is safe to use. Unaffected batches are not expected to be available until May 2015. This action has been closed-out on 31/05/2016.

Device

AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors
  • 모델명 / 제조번호(시리얼번호)
    AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier AdaptorsCatalogue number: 400340 Batch Numbers: 149137, 307137, 362137, 385137Catalogue number: 003-40B Batch Numbers: 312137, 394137, 396137, 429137Catalogue Number: 400360 Batch Number: 91136ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd