Events

Various Arrow Critical Care devices 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Teleflex 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 날짜
    2018-05-31
  • 사례 출판 날짜
    2018-05-31
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/various-arrow-critical-care-devices-recall-due-to-incomplete-packaging-seals
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Manufactured by teleflex – various critical care devices manufactured from january to december 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
  • 조치
    Refer to the manufacturer’s FSN for a list of affected products Identify, cease using and quarantine these devices Contact Arrow International to return the devices

Device

Various Arrow Critical Care devices
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Please refer to the FSN and related Appendix for a complete list of affected products. Note that Devices marked as non-CE marked are not on the EU market.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • 제조사 주소
    Ken Oshanksy Arrow International Inc. 4024 Stirrup Creek Drive NC 27703 Durham USA Tel: +1 919-433-4940Email: internationalFCA@teleflex.comCliodhna Coffey UK Customer Service Fax: +44 (0) 1494 524650 Tel: +44 (0) 1494 532761Email: orders.uk@teleflex.com
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    MHRA