Supply Issues Ebrington Medical Non-Sterile Ultrasound Gel FDK1429 (ICN 2704)

• Following an ongoing investigation, the decision has been made to discontinue the affected product pending a full resolution:
  • FDK1429 – Ultrasound Gel AquaUltra Clear 260g bottle.
• FDK1429 has now been delisted from our online catalogue.
• This ICN is now closed.

• The supply issue with Non-Sterile Ultrasound Gel from Ebrington Medical is continuing.
• One product code remains suspended and unavailable to order:
  • FDK1429 – Ultrasound Gel AquaUltra Clear 260g bottle.
• One product remains affected in total.
• Potential indirect alternative products are available to order through our online catalogue for the affected product. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• We will continue to review the stock to minimise further disruption and will update this ICN as soon as we have further information.
• The supply issue is now anticipated to be resolved by 31 October 2025.

• The supply issue with Non-Sterile Ultrasound Gel from Ebrington Medical is continuing.
• One product code remains affected in total:
  • FDK1429 – Ultrasound Gel AquaUltra Clear 260g bottle.
• FDK1429 remains suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue for the affected product. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• We will update this ICN as soon as we have further information.
• The supply issue is now anticipated to be resolved by 1 July 2025.

• The supply issue with Non-Sterile Ultrasound Gel from Ebrington Medical is continuing.
• One product code remains affected in total:
  • FDK1429 – Ultrasound Gel AquaUltra Clear 260g bottle.
• FDK1429 remains suspended and unavailable to order.
• A Field Safety Notice has been issued by the manufacturer which we advise all customers to follow.
• See our Useful Links section to view ICN 2707 for full details and updates.
• Healthcare providers, clinicians and practitioners using ultrasound gel in their practice are also recommended to follow recommendations in the UK Health Security Agency (UKHSA) guidance, for safe use of ultrasound gel which outlines measures to reduce risk to patients associated with the use of non-sterile ultrasound gel in healthcare settings.
• UKHSA previously issued a National Patient Safety Alert to ensure alignment of this guidance and the contents of this alert remain valid.
• Potential indirect alternative products are available to order through our online catalogue for the affected product.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• We will continue to review the stock to minimise further disruption and will update this ICN as soon as we have further information.
• The supply issue is now anticipated to be resolved by 31 January 2025.

• The supply issue with Non-Sterile Ultrasound Gel, FDK1429 from Ebrington Medical is continuing.
• A Field Safety Notice (FSN) has been issued by the manufacturer, which we advise all customers to follow.
• See our Useful Links to view ICN 2707 for full details and updates on the Field Safety Notice.
• Healthcare providers, clinicians and practitioners using ultrasound gel in their practice are also recommended to follow recommendations in the UK Health Security Agency (UKHSA) guidance, for safe use of ultrasound gel which outlines measures to reduce risk to patients associated with the use of non-sterile ultrasound gel in healthcare settings.
• UKHSA previously issued a National Patient Safety Alert to ensure alignment of this guidance and the contents of this alert remain valid.
• One product code is affected in total.
• FDK1429 remains suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue for the affected products.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We will continue to review the stock to minimise further disruption and will update this ICN as soon as we have further information.
• The supply issue is still anticipated to be resolved by 30 November 2024.

Please note that due to the clinical nature of these alternative products we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.

Change:

• We have been informed of an issue with Non-Sterile Ultrasound Gel, FDK1429 as supplied by Ebrington Medical.
• The issue is due to an ongoing investigation of the product, therefore, we have taken the precaution to suspend the item.
• Healthcare providers, clinicians and practitioners using ultrasound gel in their practice are recommended to follow recommendations in the UKHSA guidance for safe use of ultrasound gel which outlines measures to reduce risk to patients associated with the use of non-sterile ultrasound gel in healthcare settings.
• UKHSA previously issued a National Patient Safety Alert to ensure alignment of this guidance and the contents of this alert remain valid.

Impact:

• FDK1429 is currently suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue:
  • FDK1439 – Ultrasound Gel 250ml clear non-sterile
  • FDK85051 – Ultrasound Gel 250ml Bottle Thick Clear Non-Sterile Non-Staining Non-Irritating.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• Formal communication is anticipated to be released by the manufacturer, UKHSA and MHRA, and this ICN will be updated on its release.
• The supply issue is anticipated to be resolved by 30 November 2024.

Next Steps:              

• Customers are advised to log into our website to view the product listing for further information on the affected product code and potential alternatives.  
• The continuing supply issue is being monitored in conjunction with the supplier and relevant central agencies.
• We will continue to review the stock situation to minimise further disruption and will update this ICN with the latest information as it becomes available.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.