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Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection 

 

Summary Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients. 

 

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. 

 

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 a communication from MHRA.  

 

 

MDA/2020/004   

 

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Problem / background  

 

The manufacturer identified an issue at their manufacturing facility which means products are potentially contaminated with Burkholderia cepacia, a drug-resistant microorganism. They are now recalling all products made at this site that use the affected production method. 

 

Manufacturer contacts Mavidon Medical Tel:  +1 561 585 2227 Email: cs@mavidon.com  

 

Distribution 

 

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists. 

 

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• ENT services, directors of • Equipment stores • Equipment libraries and stores • Gastroenterology departments • Gastroenterology, directors of • General surgery • General surgical units, directors of • Gynaecologists • Gynaecology departments • Gynaecology nurses • Haematologists • Haemodialysis nurses • Haemodialysis units • Health and safety managers • Infection control departments • Infection control nurses • Infection prevention and control directors • Intensive care medical staff/paediatrics • Intensive care nursing staff (adult) • Intensive care nursing staff (paediatric) • Intensive care units • Intensive care, directors of • IV nurse specialists • Minor injury units • Maternity units • Medical directors • Microbiologists • Midwifery departments • Midwifery staff • MRI units, directors of • Neonatal nurse specialists • Neonatology departments • Neonatology directors • NHS walk-in centres • Nursing executive directors • Obstetricians • Obstetrics and gynaecology departments • Obstetrics and gynaecology directors • Obstetrics departments • Obstetrics nurses • Operating department practitioners • Ophthalmology departments • Ophthalmology, directors of • Oral surgeons • Outpatient clinics • Outpatient theatre managers • Outpatient theatre nurses • Paediatric intensive care units • Paediatric medicine, directors of • Paediatric nurse specialists • Paediatric surgery, directors of • Paediatric wards • Paediatrics departments 

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• Paramedics • Peritoneal dialysis units • Purchasing managers • Radiology departments • Renal medicine departments • Renal medicine, directors of • Resuscitation officers and trainers • Risk managers • Special care baby units • Supplies managers • Theatre managers • Theatre nurses • Theatres • Urological surgeons • Urological surgery, directors of • Urology departments • Walk-in centres 

 Public Health England  Directors for onward distribution to: • Collaborating centres • Consultants in communicable disease control • Divisional directors • Heads of department • Heads of health, safety and quality • Health protection nurses • Laboratory managers • PHE laboratories • Regional microbiologists • Risk manager • Safety officers 

 

GP Practices registered with CAS This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert. 

 

NHS England area teams  CAS liaison officers for onward distribution to all relevant staff including: • General dental practitioners • GP practices not yet registered with CAS (for information only) • Occupational health departments 

 

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert. 

 

Independent distribution 

 Establishments registered with the Care Quality Commission (CQC) (England only)  • Clinics • Hospices • Hospitals in the independent sector • Independent treatment centres • Nursing agencies • Private medical practitioners 

 

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Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility