Events

STERRAD 100S Cassettes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2014-RN-00281-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00281-1
  • 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
    The manufacturer, asp has identified that the misaligned barcodes may cause the cassette to be slightly out of position. the barcode on the sterrad 100s cassette is used to register the position of the cassette in the sterilizer. an out of position cassette may cause the first cycle on that cassette to cancel, or in extreme cases may cause the injection needles used to remove hydrogen peroxide from the sterrad 100s cassette to be damaged. the position of the barcode on the affected lots is variable and the probability of resulting damage to the injection needles is low.
  • 조치
    Johnson & Johnson Medical is advising users to continue to use current stock until a replacement product has been provided. Affected stock can be returned to Johnson & Johnson Medical once unaffected stock has been received. This action has been closed-out on 12/02/2016.

Device

STERRAD 100S Cassettes
  • 모델명 / 제조번호(시리얼번호)
    STERRAD 100S CassettesProduct Code: 10113Lot Numbers; 13I038, 13I046, 13I071, 13I072, 13I077, 13I078, 13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 & 14A031ARTG Number: 123602
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd