Events

ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Health Enterprises Inc. 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
    SN2011(10)
  • 날짜
    2011-06-01
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/acu-life-dosage-spoon-acu-life-dosage-dropper&id=9d85f825-9782-6eee-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 acu-life dosage spoons and acu-life dosage droppers have been provided to pharmacy outlets in ireland. these dosage spoons and dosage droppers are not appropriately ce marked. although they carry the ce mark, the ce mark is not accompanied by a four digit notified body number, which confirms that the measuring function aspect of the medical device has been reviewed and certified by a notified body, as required by the medical devices legislation.
  • 조치
    Advice for Pharmacies  Pharmacies and retailers should examine their stock to determine if they have any ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Atlantico Systems immediately to obtain further instruction and guidance.  Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:  (a) Do not carry the CE mark  (b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number  Advice for Consumers  Consumers should check their dosage spoons and/or dosage droppers to determine if their device is branded ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  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

ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper
  • Manufacturer
    Health Enterprises Inc.

Manufacturer

Health Enterprises Inc.