Product Recall Ebrington Medical Non-Sterile Ultrasound Gel FDK1429 (ICN 2707)

• Ebrington Medical has issued an updated Field Safety Notice following discovery of the potential risk of contamination in additional Lots, therefore the scope of the recall has widened to include Lot number 2024.06 expiry date 2027.06.

• Follow the instructions in the original ICN below and in the Field Safety Notice Update attached.

MHRA TBC

NHSSC Ref: 58

Alert:

• Ultragel Medical has issued a Field Safety Notice recalling Ebrington Medical AquaUltra clear ultrasound gel due to the potential risk of microbial contamination. The potential link with ultrasound gel was identified during an investigation by Public Health Authorities. The investigation is ongoing.
• There is a potential risk of developing infection caused by Burkholeria stabilis if the affected gel is used. The risk is higher in patients with cystic fibrosis, severe lung disease, the severe immunocompromised and intensive care patients.

Products Affected:

• The affected product has been supplied by NHS Supply Chain:

• Please note the product has been suspended with an estimated resolution date of 30 November 2024.
• See our Useful Links to view ICN 2704 for full details and updates on the supply issue.
• See our Downloads▼ section to access the product listing for further information on the affected product code and potential alternatives.

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 the affected lot number.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot number 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.
• Where potential alternatives are identified, customers are advised to consult your 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 Services Advisor or our 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.