- Identify affected devices from the manufacturer’s field safety notice (FSN)
- Quarantine, discard / destroy the charging base only as described in the FSN
- Fill in the form in the FSN and email or fax it to the manufacturer to either confirm you’re not affected or to obtain the replacement charging bases.
- All healthcare workers who use these devices.
- Personnel involved in the purchase, supply and distribution of these devices.
Deadlines for action
Actions underway: 16 September 2015, actions complete: 7 October 2015
The manufacturer is recalling lot numbers 1, 2, 3, 4, and 5 of device reference number DYND70802UK (charging base only) and lot numbers 1, 2, 3, 4, and 5 of device reference number DYND70800UK (surgical clipper and charging base in a set).
Note that the manufacturer states in the instructions for use:
“10. To avoid risk of fire or explosion, do not use near flammable anesthetics, aerosol sprays, or oxygen-administering equipment other than those administered via nasal cannulas or masks.”
Medline Int. Germany for Medline Industries
Telephone: +49 2821 7510 7210
Fax: +49 2821 7510 7822
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- all wards
- day surgery units
- ENT departments
- health and safety managers
- in-house maintenance staff
- maxillofacial departments
- neurosurgical departments
- nursing executive directors
- outpatient theatre managers
- outpatient theatre nurses
- risk managers
- supplies managers
- theatre managers
- theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only):
- hospitals in the independent sector
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 Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/032 or 2015/006/025/291/006.
Sara Vincent or Roopa Prabhakar, MHRA
Tel: 020 3080 7169 / 7293
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
Through the Yellow Card website.
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Report directly to NIAIC using the forms on the website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS boards and local authorities in Scotland should report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624 / 02920 825 510