Field Safety Notice Advance Medical Designs Turkuaz Medical Sterile Ultrasound Gel and Associated Products (ICN 2248)

MHRA TBC

NHSSC Ref: 43

Alert:

• The supplier Advance Medical Designs has issued a Field Safety Notice for a precautionary recall of Turkuraz Medical Sterile Ultrasound Gel and Convenience Kits which contain Turkuraz Medical Sterile Ultrasound Gel as a component, due to a mislabelling issue.
• The instructions for use state that the gel can be used internally, but the correct instruction for use is for use on intact skin only.
• The gel packets with the Lot numbers listed in the Field Safety Notice are considered mislabelled.

Products Affected:

•  Five of these product codes are available from NHS Supply Chain.

• Please note only the Lot numbers listed in the Field Safety Notice are affected.

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 affected batches.
• Complete the Response Form on pages 11-12 whether you have affected product or not, by emailing it to: carriefarmer@advmeddes.com
• Advance Medical Designs will arrange collection of the affected products in your possession.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products including National Product Code, Lot numbers and quantity stating whether boxes or eaches. This will enable us to offer support or raise credit on your behalf, as necessary.
• 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.