Field Safety Notice Ethicon Sutures Absorbable Products (ICN 2250)

Alert:

• Ethicon has issued a Field Safety Notice for the precautionary recall of a range of sutures and Lot numbers following seven complaints against one Lot of undyed PDS™ II (polydioxanone) Sutures regarding low tensile strength.
• Ethicon advised internal testing on returned products from this Lot confirmed that some PDS™ II (polydioxanone) Sutures from this Lot did not meet Ethicon’s tensile strength requirement.
• Further investigation by the manufacturer identified additional Lots across the PDS™ Plus Antibacterial (polydioxanone) and PDS™ II (polydioxanone).
• Failure in suture tensile strength could potentially result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved.
• In such an instance the potential harms would include bleeding/haemorrhage, treatment failure/wound dehiscence, surgery prolonged and surgery intervention.
• Ethicon advises none of these potential harms have been reported to occur and none of the complaints received reported patient consequences to date.
• Healthcare practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required.

Products Affected:

• These products are available from NHS Supply Chain and eDirect services.
• Please note only the Lot numbers listed in the Field Safety Notice on Attachment 1 page 3 onwards are affected.
• NHS Supply Chain’s stock has been checked and all future issues will be of unaffected Lot numbers.

Next Steps:                                

• Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Cease use and quarantine all affected Lot numbers.
• Complete and return the Business Reply Form (BRT), pages 11 and 12 of the field safety notice, as soon as possible, even if you have no product for return by emailing MDFieldActionsUKirl@its.jnj.com
• Please ensure your contact details are clear to enable Ethicon to contact you to arrange the collection of the products supplied on the eDirect Service.
• Where affected product or Lot numbers of the sutures stocked at NHS Supplies are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall). Please confirm if the quantity of product to be returned is a single-pack unit of issue.
• All goods are to be returned by Friday 24 September 2023.
• Where potential alternatives are identified, Customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.