Amended Instructions for Use TriTemp Thermometer TR1 (ICN 1104)

Important Customer Notice Field Safety Notice

Ref: 2020/1104 ICN Number: 1104

MHRA: 2020/007/021/291/004
NHSSC : 37

Alert:

  • Henleys Medical is distributing an advisory Field Safety Notice on behalf of the manufacturer Trimedika.
  • It has been discovered users may unintentionally access the MODE settings when using the TriTemp TR1 thermometer.
  • A revised Instructions for Use has been provided to ensure that if you inadvertently enter the MODE settings you will be aware of this action and will understand how to exit these settings.

Products Affected:

  • This product is available via NHS Supply Chain’s eDirect route as NPC FWH238 – Thermometer temporal artery device – MPC TR1 Tritemp.

Next Steps:

  • Follow the actions recommended in the manufacturer’s Field Safety Notice.See our Downloads ▼ section.
  • Please ensure the new instructions for use are distributed to all end users.
  • Complete and return Henley’s Medical Field Safety Notice acknowledgement form found on page 5, to vikki.patis@henleysmed.com as soon as possible.
  • Please note there is no need to return any product to Henleys Medical or Trimedika.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1104 Henleys Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1104.
  • 1104 TriMedika Field Safety Notice

    A PDF of TriMedikas Field Safety Notice for ICN 1104.
  • 1104 TriTemp Instructions For Use

    A PDF of the Instructions For Use for ICN 1104