Events

‘First Steps’ Medicine Feeder 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 RSW International Limited 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
    Field Safety Notice
  • 사례 연번
    SN2009(05)
  • 날짜
    2009-06-18
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/first-steps-medicine-feeder&id=4c99f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    Non-compliant ‘first steps’ medicine feeders have been provided to retail outlets in ireland by rsw international limited. these medicine feeders are not appropriately ce marked.
  • 조치
    Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range.  If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB. Advice for Consumers  Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range.  If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.

Device

‘First Steps’ Medicine Feeder
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ‘First Steps’ Medicine Feeder
  • Manufacturer
    RSW International Limited

Manufacturer

RSW International Limited