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 (MDA/2020/004)

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

Product information

MDA number

MDA/2020/004

Company name

Mavidon Medical

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.

Deadlines for actions

Actions underway: 19 February 2020 Actions complete: 4 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 a communication from MHRA.

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.

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • A&E consultants
  • A&E departments
  • A&E directors
  • A&E nurses
  • Adult intensive care units
  • Ambulance services directors
  • Ambulance staff
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Cardiac laboratory technicians
  • Cardiac pacing technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Cardiothoracic surgeons
  • Cardiothoracic surgery directors
  • Clinical governance leads
  • Colposcopy departments
  • Community hospitals
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • Dental departments
  • Dental nurses
  • Dentists
  • Endocrinology units
  • Endocrinology, directors of
  • ENT departments
  • ENT medical staff
  • 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
  • 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

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.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2020/004 or 2020/001/007/228/002.

Technical aspects

Phillip Davenport, MHRA Tel: 020 3080 6000 Email: DSS-TM@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA Tel: 020 3080 7274 Email: dct@mhra.gov.uk

To report an adverse incident involving a medical device in England use the Yellow Card reporting page.

Northern Ireland

Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland) Tel: 028 9052 3868 Email: niaic@health-ni.gov.uk

To report an adverse incident involving a medical device in Northern Ireland use the forms on the website. Alerts in Northern Ireland are distributed via the NICAS system.

Scotland

Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland Tel: 0131 275 7575 Email: nss.iric@nhs.net

To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident

Wales

Population Healthcare Division, Welsh Government Tel: 03000 255278 or 03000 255510 Email: Haz-Aic@gov.wales

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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

Published 5 February 2020