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Originator: MHRA Medical Device Alerts

Issue date: 21-Jun-2018 11:00:24

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: Immediate Action

Title: Alaris Smartsite Add-On Bag Access device - removal and destruction of specific batches due to risk of disconnection or leakage

Broadcast content: Manufactured by BD (formerly Carefusion) – specific batches manufactured from July 2015 to Sept 2016 inclusive.  Risk of leakage or disconnection of tubing caused by inadequately sealed connections.   This may cause delay to infusion, under infusion, or exposure to hazardous infusates.

Additional information: Do not cascade to primary care.

Alert reference: MDA/2018/021

Action underway deadline: 12-Jul-2018

Action complete deadline: 02-Aug-2018


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency