Supply Issues Salter Labs UK (formerly Vyaire) DeRoyal Temperature Probes and Sensors FKA801, FKA802 and FKA804 (ICN 2428)

• The supplier Salter Labs UK has informed us to delist the affected DeRoyal Temperature Probes and Sensors until regulatory approval is granted.
• Three product codes are in the process of being delisted from our online catalogue:
  • FKA801 -Temperature Probes and Sensors Skin Temperature Sensor 400 Series sterile
  • FKA802 – Temperature Probes and Sensors General Purpose Temperature Probe 9FR 400 Series 50 CS
  • FKA804 – Temperature Probes and Sensors General Purpose Temperature Probe 12FR 300 Series 50 CS.
• The affected product codes have now been suspended for over six months which is beyond the time permitted to suspend products.
• Once regulatory approval has been granted the delisted product codes will once again be made available to order.
• Stock of each product code is available at the supplier’s premises.
• This ICN is now closed.

• The supply issue with DeRoyal Temperature Probes and Sensors from Salter Labs UK is continuing.
• The affected product codes remain suspended and unavailable to order:
• • FKA801, FKA802 and FKA804.
• Three product codes remain affected in total.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. 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 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.
• DeRoyal are in the final phases of appointing a new distributor for their products, once this is completed DeRoyal will register their products on EUDAMED and then with MHRA.
• The supplier is expediting the regulatory issue with the manufacturer (DeRoyal) where possible but reliant on the manufacturer to finalise and awaits approval from regulatory bodies.
• Stock is in the UK and available for distribution once the regulatory bodies issue acceptance.
• The supply issue is now anticipated to be resolved by 14 October 2024.

• The supply issue with DeRoyal Temperature Probes and Sensors from Salter Labs UK is continuing.
• The affected product codes remain suspended and unavailable to order:
• • FKA801, FKA802 and FKA804.
• Three product codes remain affected in total.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. 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 codes and potential alternatives.
• DeRoyal are in the final phases of appointing a new distributor for their products, once this is completed DeRoyal will register their products on EUDAMED and then with MHRA.
• The supplier is expediting the regulatory issue with the manufacturer (DeRoyal) where possible but reliant on the manufacturer to finalise and await approvals from regulatory bodies.
• We will update this ICN as soon as we have further information.
• The supply issue is now anticipated to be resolved by 18 September 2024.

• The supply issue with DeRoyal Temperature Probes and Sensors from Salter Labs UK is continuing.
• The affected product codes remain suspended and unavailable to order:
• • FKA801, FKA802 and FKA804.
• Three product codes remain affected in total.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. 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 codes and potential alternatives.
• DeRoyal are in the final phases of appointing a new distributor for their products, once this is completed DeRoyal will register their products on EUDAMED and then with MHRA.
• The supplier is expediting the regulatory issue with the manufacturer (DeRoyal) where possible but reliant on the manufacturer to finalise and await approvals from regulatory bodies.
• 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 5 August 2024.

• The supply issue with DeRoyal Temperature Probes and Sensors from Salter Labs UK is continuing.
• Three product codes remain affected in total:
  • FKA801, FKA802 and FKA804.
• The affected product codes remain suspended and unavailable to order.
• DeRoyal are in the final phases of appointing a new distributor for their products, once this is completed DeRoyal will register their products on EUDAMED and then with MHRA.
• The supplier is expediting the regulatory issue with the manufacturer (DeRoyal) where possible but reliant on the manufacturer to finalise and await approvals from regulatory bodies.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. 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 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 now anticipated to be resolved by 12 July 24.

• The supply issue of DeRoyal products from Salter Labs has informed us that the supply issue is continuing.
• Three product codes remain affected in total.
  • FKA801, FKA802 and FKA804.
  • The affected product codes remain suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. 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. We will update this ICN as soon as we have further information.
• The supplier is expediting the regulatory issue with the manufacturer DeRoyal and has advised that the anticipated recovery date is to be resolved by 28 May 2024.

Change:

• The supplier Salter Labs UK has informed us of a supply issue with its DeRoyal products.
• There are three product codes affected:
  • FKA801 – Skin Temperature Sensor 400 Series sterile
  • FKA802 – General Purpose Temperature Probe 9FR 400 Series 50 CS
  • FKA804 – General Purpose Temperature Probe 12FR 300 Series 50 CS.
• The supply issue is due to supplier manufacturing issues.
• The manufacturer is in the process of appointing a UK representative, the current distributor has had to suspend sales until resolved.
• No clinical or patient safety impact.

 Impact:          

• All the affected product codes are currently unavailable to order, pending suspension within coming days.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is anticipated to be resolved by 4 March 2024.

 Next Steps:               

• Customers are advised to log into our website to view the potential indirect alternative products.
• That alternative suggested products are similar and listed within the Information for Clinical Choice (ICC) documents, minimal training required when using the alternatives.
• The continuing supply issue is being monitored in conjunction with the supplier and we will continue to review the stock situation to minimise further disruption and update this ICN with the latest information as it becomes available.
• However, as this is currently a disrupted market and supply is subject to rapid change, the alternatives offered may also be experiencing temporary supply issues and therefore, customers may need to consider clinically reviewing all additional alternatives provided.
• We will update the ICN when we have further information.
• 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.