Events

Field Safety Notices about Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S

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
  • Date
    2009-04-02
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-insulin-pen-needles-novofine-needles-31g-0.25mm-x-6mm-lot-number-08j02s&id=0a8df825-9782-6eee-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
    The mhra in the united kingdom have issued a medical device alert (mda/2009/021) concerning counterfeit novofine 31g insulin pen needles, 0.25m x 6mm in circulation in the united kingdom.  it is highly unlikely that the counterfeit needles have been manufactured to the appropriate standards.  the insulin used including the pen injection device is not affected.   to date, there is no evidence that these counterfeit products have been placed on the irish market.  lot number 08j02s is the only affected lot number.  there is no genuine product on the irish market with the same lot number.    as a precautionary measure, the imb are requesting that consumers and pharmacies check the lot number on the protective tab for the needle and on the carton label for the affected lot number.    the imb are advising pharmacies to examine their stock and immediately cease sales of lot number 08j02s.    should consumers have any of the counterfeit needles, the imb advise consumers to return any affected product to their local pharmacy and those with health concerns should consult with their general practitioner.   please notify the imb immediately if you have any novofine needles 31g, 0.25m x 6mm, lot number 08j02s.   the imb will continue to monitor this issue closely along with our colleagues in the united kingdom.

Device

Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S
  • Model / Serial
  • Product Description
    Counterfeit Insulin Pen Needles – Novofine® Needles 31G, 0.25mm x 6mm, Lot Number 08J02S
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA