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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of SurgiMend® and PriMatrix® products due to issues with the in-process and finished goods endotoxin testing

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 August 2023

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 Humedical (S) Pte Ltd to inform healthcare professionals that issues have been identified with the in-process and finished goods endotoxin testing which may result in out of specification endotoxin results. The affected products are SurgiMend®, SurgiMend® MP, SurgiMend® PRS, SurgiMend® PRS Meshed, PriMatrix® Dermal Repair Scaffold and PriMatrix® Ag Antimicrobial Dermal Repair Scaffold. Potential harms due to high levels of endotoxins include low-grade fever, inflammation, and/or inflammatory response leading to fever (pyrexia), and/or surgical intervention/revision surgery. Healthcare professionals are advised to examine their inventories, quarantine affected products and return these affected products immediately. They are advised to monitor patients who have been implanted with these products and treat them based on their medical judgment and patients’ symptoms. 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 (opens in new tab) 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.