Voluntary product recall of specific lots of undyed PDS™ II (polydioxanone) Sutures and undyed PDS™ Plus Antibacterial (polydioxanone) Sutures

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte. Ltd. to inform healthcare professionals of a voluntary product recall of specific lots of undyed PDS™ II (polydioxanone) Sutures and undyed PDS™ Plus Antibacterial (polydioxanone) Sutures, which may not meet Ethicon's tensile strength requirement. Failure in suture tensile strength could result in poor performance of the affected product where the intended benefit of tissue approximation and/or ligation may not be achieved. Healthcare professionals are advised to examine their inventories, quarantine affected products and return these affected products immediately. Healthcare professionals who have treated patients using the affected products are advised to follow up these patients post-operatively in the usual manner. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

23 Aug 2023

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), 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: Select your profession under 'For Healthcare Professionals’.

Step 2: Click on 'Restricted Content' and log in via SingPass.

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

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