1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator Tapes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M 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-2017-RN-00635-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-05-19
  • 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
    During a recent investigation, the manufacturer confirmed some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • 조치
    3M Australia is requesting users to discontinue use of affected products and notify 3M to receive a refund or replacement. Distributors are requested to cease distribution of affected products and forward the recall notification to customers who have received the affected lots. Distributors are further requested to consolidate returned products from their customers with their own affected stock and notify 3M accordingly to receive a refund or replacement.

Device

  • 모델명 / 제조번호(시리얼번호)
    1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps 1322 3M Comply Lead Free Steam Indicator TapesStock Numbers: CT060934651 & CT060934669Roll Sizes: 1322-18MM & 1322-24MM (respectively)1355 3M Comply Lead Free Steam Indicator Tapes for Disposable WrapsStock Numbers: CT060934693 & CT060934701Roll Sizes: 1355-18MM & 1355-24MM (respectively)Lot No: 2018-04RA, 2018-05RB, 2018-06RC & 2018-06RD ARTG Number: 126363
  • Manufacturer

Manufacturer