Voluntary recall due to potential for packaging integrity issues of specific Polysorb™ braided and Biosyn™ monofilament absorbable sutures

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to notify healthcare professionals of the voluntary recall of specific production lots of Polysorb™ braided and Biosyn™ monofilament absorbable sutures due to potential for packaging integrity issues impacting the humidity or sterility barrier of these absorbable sutures. Potential risks associated with the issues include premature degradation of the suture material and compromise of the product’s sterility. There have been no reports of patient injuries associated with these issues. Healthcare professionals are advised to quarantine, discontinue use and return all unused affected products to Medtronic. Healthcare professionals who have treated patients using the affected devices should continue to follow-up with these patients post-operatively in the usual manner. Please refer to the letter for details.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

14 Jan 2020

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.