Recall of specific lots of Medtronic non-absorbable sutures due to sterile barrier breach

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd to inform healthcare professionals of a recall of specific lots of the Medtronic non-absorbable sutures due to potential sterile barrier breach as manufacturing errors in the packaging may cause a gap or wrinkle in the breather pouch seal. A sterile barrier breach may lead to infection or vision loss for ophthalmic procedures where there is direct patient contact. Healthcare professionals are advised to identify and quarantine all unused and non-expired affected non-absorbable sutures and return them to Medtronic. As there are no additional patient management recommendations for patients where potentially affected non-absorbable sutures were used during a procedure, healthcare professionals are advised to monitor them in accordance with the medical facility's standard care protocols with consideration to the specific use. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

9 Dec 2022

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.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

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

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