Events

Field Safety Notices about AidFast, 1st Aid & Powerplast Digital Thermometers

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2009(03)
  • Date
    2009-04-23
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source 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
  • Notes / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    AidFast, 1st Aid & Powerplast Digital Thermometers
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA