Update on recall of specific lots of Surgilon™ and Sofsilk™ Braided Sutures, Monosof™ and Steel Monofilament Sutures, and Ti-Cron™ Coated Braided Sutures

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited as a follow-up to their communication in December 2023, to update healthcare professionals on a voluntary recall of additional lots of Sofsilk™ Braided Silk sutures and specific lots of Surgilon™ Braided Nylon sutures, Monosof™ Monofilament Nylon Sutures, Ti-Cron™ Coated Braided Polyester Sutures and Steel Monofilament Stainless Steel Sutures. These were sterilised with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilisation cycles. The affected lots are expected to have reduced tensile strength over time, resulting in harms such as wound dehiscence, haemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, malunion of bone (Steel Suture), vision loss (when used in ophthalmic application), and/or prolonged surgery. Healthcare professionals are advised to identify, quarantine and return all unused and non-expired affected sutures to Medtronic. Healthcare professionals who have treated patients using the affected products are advised to continue to monitor these patients in accordance with their medical facility’s standard care protocols. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

5 Feb 2024

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.