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Health Sciences Authority
Dear Healthcare Professional Letters

Discrepancies in the RelayPlus and Relay85 Instructions for Use

Audiences

Healthcare professional

Industry member

Product type

Medical devices

28 June 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Terumo Singapore Pte Ltd to inform healthcare professionals of discrepancies in the Instructions for Use (IFUs) for RelayPlus and Relay85 devices. There were errors in the distal landing zones and several outer sheath sizes listed in the RelayPlus IFU while the landing zone recommendations were not listed for graft sizes 30 to 38mm in the Relay85 IFU. There is no defect or malfunction of the RelayPlus and Relay85 devices. Healthcare professionals are advised to refer to the target landing zone for distal length in the updated IFUs. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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