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Originator: MHRA Medical Device Alerts

Issue date: 16-Jan-2020 12:04:13

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

Information to recipients:
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Primary Care Networks

Action category: Action

Title: Convex two-piece skin barriers (Natura /Surfit /Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier

Broadcast content: Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole.

Additional information: This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
NHS England Regional offices: please cascade this alert to:
• Community pharmacists
• GP practices not yet registered with CAS (for information only)

Alert reference: MDA/2020/002

Action underway deadline: 30-Jan-2020

Action complete deadline: 13-Feb-2020


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Medicines and Healthcare products Regulatory Agency