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Originator: MHRA Medical Device Alerts

Issue date: 12-Jul-2018 15:02:47

Action by recipients:
  • Acute Trusts
  • Learning Disabilities Trusts
  • Mental Health & Learning Disabilities
  • Community Trusts
  • Care Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices

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

Action category: Action

Title: Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use

Broadcast content:

This is a re-issue of MDA/2018/025 with an amendment made under sub heading background. 

CAS LO's please close MDA/2018/025 as "action not required" and add in the free text alert superseded by MDA/2018/025R


Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment



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

Alert reference: MDA/2018/025R

Action underway deadline: 08-Aug-2018

Action complete deadline: 05-Sep-2018

Attachments:

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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency