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Originator: MHRA Medical Device Alerts

Issue date: 19-Mar-2019 11:00:06

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Special Health Authorities

Action category: Action

Title: enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer

Broadcast content: Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Additional information: NHS England Regional offices:
do not cascade to primary care.


Alert reference: MDA/2019/016

Action underway deadline: 26-Mar-2019

Action complete deadline: 10-Apr-2019

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency