Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient

Manufactured by Unomedical Inc / Convatec Ltd – recall due to a manufacturing fault (MDA/2016/001)

Action

Actions for end users:

  • Identify affected devices as described in the manufacturer’s field safety notice (FSN) and quarantine them
  • Complete and return the confirmation form in the FSN
  • Return all affected products to your distributor for credit or replacement

Action by

All healthcare workers who use these devices.

Deadlines for actions

Actions underway: 23 February 2016, actions complete: 22 March 2016

Device details

This recall affects specific product codes and associated lots/batches of nebulizers and nebulization kits.

See manufacturer’s FSN for a list of affected products.

Manufacturer contacts

Manufacturer:

Convatec

Telephone: 01244 832 206

unomedical-uk.customerservices@convatec.co.uk

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 SABS (NI) 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
  • all departments
  • all staff
  • all wards
  • ambulance services directors
  • ambulance staff
  • anaesthesia, directors of
  • anaesthetic medical staff
  • anaesthetic nursing staff
  • anaesthetists
  • cardiologists
  • cardiology departments
  • cardiology nurses
  • cardiology, directors of
  • cardiothoracic departments
  • cardiothoracic surgeons
  • cardiothoracic surgery directors
  • clinical governance leads
  • community children’s nurses
  • community hospitals
  • community nurses
  • coronary care departments
  • coronary care nurses
  • day surgery units
  • district nurses
  • eNT departments
  • eNT medical staff
  • eNT services, directors of
  • general surgery
  • general surgical units, directors of
  • haemodialysis nurses
  • haemodialysis units
  • health and safety managers
  • hospital at home units
  • intensive care medical staff/paediatrics
  • intensive care nursing staff (adult)
  • intensive care nursing staff (paediatric)
  • intensive care units
  • intensive care, directors of
  • medical directors
  • medical libraries
  • midwifery departments
  • midwifery staff
  • outpatient clinics
  • outpatient theatre managers
  • outpatient theatre nurses
  • paediatric intensive care units
  • paediatric medicine, directors of
  • paediatric nurse specialists
  • paediatric oncologists
  • paediatric wards
  • paediatrics departments
  • palliative care teams
  • paramedics
  • physiotherapists
  • purchasing managers
  • resuscitation officers and trainers
  • risk managers
  • school nurses
  • supplies managers
  • theatre managers
  • theatres
  • walk-in centres

Public Health England

Directors for onward distribution to:

  • risk manager
  • safety officers

NHS England area teams

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

  • general practitioners
  • general practice managers
  • general practice nurses

Social services

Liaison officers for onward distribution to all relevant staff including:

  • care at home staff
  • care management team managers
  • children’s disability services
  • dommunity care staff
  • day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
  • education departments for equipment held in schools
  • equipment stores
  • equipment supplies managers
  • in-house domiciliary care providers (personal care services in the home)
  • in-house residential care homes
  • loan store managers
  • loaned equipment store managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • adult placement
  • care homes providing nursing care (adults)
  • care homes providing personal care (adults)
  • clinics
  • domiciliary care providers
  • further education colleges registered as care homes
  • hospices
  • hospitals in the independent sector
  • independent treatment centres
  • nursing agencies
  • private medical practitioners

Establishments registered with OFSTED

  • children’s services
  • educational establishments with beds for children
  • residential special schools

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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2016/001 or 2015/011/020/051/003

Technical aspects

Leanne Simpson and Elke Kerwick
MHRA

Telephone: 020 3080 7143 / 6826

leanne.simpson@mhra.gsi.gov.uk and elke.kerwick@mhra.gsi.gov.uk

Clinical aspects

Dr S Jagdish
MHRA

Telephone:020 3080 7187 s.jagdish@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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
CMO Group,
Department of Health, Social Services and Public Safety

Telephone: 028 9052 3868

Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our website.

Scotland

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

Email: nss.iric@nhs.net

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.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division
Welsh Government

Telephone: 02920 823 624/02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

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Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient

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