Identify affected devices from the manufacturer’s field safety notice (FSN).
Quarantine and return the devices to the manufacturer as described in the FSN.
Return the email / faxback form in the FSN to the manufacturer.
All healthcare workers who use these devices.
Personnel involved in the purchase, supply and distribution of these devices.
Deadlines for actions
Actions underway: 18 August 2015, actions complete: 02 September 2015
All batches of automatically retracting blue safety syringes, including insulin syringes, with product codes prefixed with RN, for example RNXX/XX and RNXX/XX INS.
Medicina Ltd has not had sufficient confirmation that customers have received and acted on the FSN.
Telephone: 01204 695 050
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:
- A&E departments
- adult intensive care units
- all wards
- chief pharmacists
- clinical governance leads
- community children’s nurses
- community diabetes specialist nurses
- community hospitals
- community nurses
- day surgery units
- diabetes clinics/outpatients
- diabetes nurse specialists
- diabetes, directors of
- district nurses
- health and safety managers
- hospital at home units
- hospital pharmacies
- immunisation co-ordinators
- maternity units
- medical directors
- nursing executive directors
- paediatric intensive care units
- paediatric medicine, directors of
- point of care testing co-ordinators
- purchasing managers
- risk managers
- supplies managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- community pharmacists
- general practice managers
- general practice nurses
Liaison officers for onward distribution to all relevant staff including:
- care at home staff
- community care staff
- in-house residential care homes
Establishments registered with the Care Quality Commission (CQC) (England only)
- adult placement
- care homes providing nursing care (adults)
- further education colleges registered as care homes
- hospitals in the independent sector
- independent treatment centres
- 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 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/2015/028 or 2015/006/025/601/007.
Claire Dunne / Sonal Vara, MHRA
Tel: 020 3080 7162 / 7710
Mark Grumbridge, MHRA
Telephone: 020 3080 7128
Reporting adverse incidents in England
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
Please report directly to NIAIC using the forms on our 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 – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 01267 225278 / 02920 825510