Field Safety Notice – Ethicon Sutures

8th August 2023

Dear Customer,

Ethicon Johnson& Johnson Surgical Technologies is undertaking  Voluntary Product Recall recalling listed batches PDS™ II (polydioxanone) Suture & PDS™ Plus Antibacterial (polydioxanone) Suture which are detailed in the table below. You can also read the Field Safety notice by clicking here.

This voluntary removal stems from Ethicon receiving several complaints for one lot of undyed PDS™ II (polydioxanone) Sutures regarding low tensile strength. Internal testing on returned product from this lot confirmed that some PDS™ II (polydioxanone) Sutures from this lot did not meet Ethicon’s tensile strength requirement. An investigation identified  additional  lots  across  the  PDS™  Plus  Antibacterial  (polydioxanone) and  PDS™  II  (polydioxanone) Suture families that have the potential to be affected by the same root cause as the lot that received the complaints.

The voluntary recall has affected the following batches of 12 NVS product codes detailed within the tables below:

What to do next – Please examine your stock immediately and take the following steps.

I have the affected product

• Quarantine the product.
• If you have any of the affected stock, then please contact our Customer Services Team on 01782 771111 (Option 3) to arrange the return of the products.
• This affected product will only be accepted until 31st August 2023, after this date we will not accept this product.

I do not have this product

• If you don’t have any of the products listed above, no further action is required.

If you require any further information, please contact our Customer Service Department on 01782 771 111.

Kind regards,

Andrew Duxbury

(Responsible Person)