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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of specific lots of PDS™ II, PDS™ Plus Antibacterial, PROLENE™ Polypropylene and ETHIBOND EXCEL™ Polyester sutures due to issue with needle coating

Audiences

Healthcare professional

Industry member

Product type

Medical devices

11 March 2025

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 Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals of the voluntary recall of specific lots of PDSTM II (polydioxanone), PDSTM Plus Antibacterial (polydioxanone), PROLENETM Polypropylene and ETHIBOND EXCELTM Polyester sutures due to an issue with a raw material used to coat some surgical needles which could result in diminished performance and/or removal of some silicone needle coating during use. Risks of using the affected products include needles sticking to the needle holder, adherence of silicone residue to the tissue surface or increase in needle penetration force. Silicone residue from the needle could lead to a local inflammatory response or delay the surgical procedure. Theoretically, silicone residue from the needle coating could enter the blood stream and present an embolic risk if the affected products are used in cardiovascular procedures. Healthcare professionals are advised to identify, quarantine and return all the affected products. Those who have treated patients using these affected products should follow them post-operatively in the usual manner with no additional action required. 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 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.

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