Field Safety Notice Vernacare International Limited Woundcare Procedure Pack EVJ017 (ICN 2783)

NHSSC: 84

Alert:

• Vernacare International Limited has issued a Field Safety Notice regarding specific Lots of their Procedure Packs due to lack of appropriate symbology following the May 2024 EU Medical Device Regulation 2017/745 implementation.
• The supplier advises no associated harm identified to patient or user and this is a regulatory and compliance risk only.

Products Affected:

• One of the products affected is available from NHS Supply Chain:

• Please note only the Lot numbers noted in the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.
• NHS Supply Chain has not transacted any affected Lots of eDirect product EVS86950 – Renal Pack (MPC 28765).

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, Lot numbers and quantity.
• Your Customer Services Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

If you have any 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.