Events

Avis De Sécurité sur AidFast, 1st Aid & Powerplast Digital Thermometers

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2009(03)
  • Date
    2009-04-23
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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
  • Notes / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    AidFast, 1st Aid & Powerplast Digital Thermometers
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA