This content is first seen at HSA website.
Disclaimer: The information provided in this site is correct at the time of publication. POMConnect assumes no responsibility or liability for any errors or omissions in the content of this site.
Voluntary product recall of specific lots of undyed PDS™ II (polydioxanone) Sutures and undyed PDS™ Plus Antibacterial (polydioxanone) Sutures
Johnson & Johnson International (Singapore) Pte. Ltd. has issued a letter addressed to healthcare professionals.
The purpose of the letter is to notify healthcare practitioners about a voluntary recall of certain batches of undyed PDS™ II (polydioxanone) Sutures and undyed PDS™ Plus Antibacterial (polydioxanone) Sutures.
This recall has been initiated due to the possibility that these specific lots might not meet Ethicon’s required tensile strength standard. In cases where the suture’s tensile strength is compromised, there is a risk of the affected product not performing as intended, which could lead to unsuccessful tissue approximation and/or ligation.
Healthcare providers are strongly advised to review their current stock, isolate the affected items, and promptly return them.
Additionally, healthcare professionals who have utilized these impacted products in patient care are recommended to continue with their usual post-operative monitoring for these patients.
Link to the full announcement (HSA DHCPL):
