Source: Medicines & Healthcare products Regulatory Agency (MHRA)
Summary
The skin preparation electrode gel, manufactured by Mavidon, is being recalled due to risk of contamination and transmission of infection from the drug-resistant microorganism Burkholderia cepacia. This product recall includes LemonPrep, PediPrep, WavePrep and Cardio Prep, which were manufactured at the same site and have all potentially been affected.
Action
- Identify and quarantine all lots of the affected products in your organisation, using the manufacturer’s field safety notice
- If you have the affected products, fill in the recall form in the FSN and return it to the manufacturer
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not
Action By
All responsible for the use of these devices
Deadlines for actions
Actions underway: 19th February 2020
Actions complete: 4th March 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for communication from MHRA.