Events

AidFast, 1st Aid & Powerplast Digital Thermometers 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 N/A 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(03)
  • 날짜
    2009-04-23
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aidfast-1st-aid-powerplast-digital-thermometers&id=2d93f825-9782-6eee-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 and inaccurate (up to 0.5°c) aid fast, 1st aid and powerplast digital thermometers have been provided to discount outlets in ireland.  these digital thermometers are not appropriately ce marked.  these thermometers may be marketed under a variety of brands and the packaging may vary.
  • 조치
    Advice for Pharmacies, Retailers and Wholesalers  Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices branded Aid Fast, 1st Aid or Powerplast digital thermometers.   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 digital thermometers that do not clearly identify the manufacturers name and address on the packaging, please advise the IMB.   Advice for Consumers Consumers should check their digital thermometer to determine if their device is branded Aid Fast, 1st Aid or Powerplast.   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

AidFast, 1st Aid & Powerplast Digital Thermometers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    AidFast, 1st Aid & Powerplast Digital Thermometers
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA