Field Safety Notice Wyvern Medical Dental Products (ICN 2177)

MHRA TBC

NHS Supply Chain Reference: 21

Please be advised the lot numbers and expiry dates have been corrected following a system error.

Alert:

• Wyvern Medical has issued a Field Safety Corrective Action Notice following the discovery that a number of products were dispatched to their warehouse prior to some of the normal test results being reviewed by the contract manufacturer’s QA department. This is contra to the agreed procedure.
• A subsequent review of the Bioburden test results, and a retesting of the same batch confirms that some of these products did not meet the necessary standards.

Products Affected:

• The affected products / lot number combinations have been supplied on NHS Supply Chain’s eDirect Service:

• Please note only the lot numbers quoted are affected.
• IEZ259 and IEZ255 are the same product supplied in different pack sizes.
• Please note Saliveze Dry Mouth Spray – lot Number 42151/09, expiry date March 2026 has not been supplied via NHS Supply Chain.
• These products are currently suspended, it is estimated unaffected products will be available in early July 2023.

Next Steps:

• Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
• If applicable, include end users, doctors, nurses, and risk managers, in the distribution list for this Field Safety Corrective Action.
• Cease use and quarantine the affected lot numbers with immediate effect, and arrange disposal in accordance with your local regulations
• Complete the “Confirmation Notice” and forward as soon as possible by emailing info@wyvernmedical.co.uk
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including NPC, lot numbers and quantity stating whether they are boxes or eaches.
• Your Customer Service 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.
• 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.