Field Safety Notice Johnson & Johnson ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row) FTX7610 (ICN 2927)

Alert:

• Johnson & Johnson has issued a Field Safety Notice regarding ENDOPATH ECHELON™ Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row) product code VASECR35, distributed since 30 May 2024 and with expiration dates starting from 31 August 2026 to help ensure safe and effective use.
• Ethicon Endo-Surgery, LLC has received an increase in reports regarding inadvertent instrument lockout during surgical procedures.
• If a user encounters this issue the device will momentarily activate but will not cut or staple tissue and additional steps will be required to open it and remove it from tissue.
• This Field Safety Notice includes reinforcement of mitigating instructions for addressing lockouts, which can be found in the current Instructions for Use (IFU).

Products Affected:

• The affected product is available via NHS Supply Chain eDirect route.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• This Field Safety Notice is a notification only and is not a product removal.
• Confirm that personnel using the affected product, understand the Instructions for Use (IFU) for the ECHELON™ Flex Powered Vascular Stapler (product code PVE35A) and this Field Safety Notice.
• Complete the Business Reply Form (BRF) Attachment 2, page 6 of the notice, confirming receipt of this notice and email it to MDFieldActionsUKirl@its.jnj.com. Please return the BRF even if you do not have product subject to this Field Safety Corrective Action.
• If you have any concerns or further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/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.