- Medicines and Healthcare products Regulatory Agency
- 21 April 2017
- 21 April 2017
- Alert type:
- Medical device alert
Manufactured by Teleflex – failure of the device to deliver an atomised plume may impair the effectiveness of the medication, potentially resulting in serious injury or a life-threatening situation
Identify and quarantine affected devices (details below)
Contact Teleflex to acknowledge receipt of their field safety notice (FSN), dated 28 October 2016, even if you don’t have affected devices left in stock
Return all affected devices to Teleflex.
All healthcare workers who use these devices.
Deadlines for actions
Actions underway: 05 May 2017
Actions complete: 21 June 2017
Teleflex Customer Service
Tel: 01494 532 761
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
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff *Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
Establishments registered with the Care Quality Commission (CQC) (England only):
- 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 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/2017/007.
Emma Rooke and Hiten Patel, MHRA
Tel: Tel: 020 3080 6609 / 020 3080 6115
MHRA Devices Clinical Team
Tel: 020 3080 7274
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
Tel: 028 9052 3868
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
Tel: 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,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 21 April 2017
Issued: 21 April 2017
Alert type: Medical device alert