Supply Issues KCI Medical Ltd Fluid Warming Products FSB658, FSB934, FVR85003 and FFF430 (ICN 3065)

• The supply issue with Fluid Warming products from KCI Medical Ltd is now resolved.
• FSB658, FSB934 and FVR85003 are now available to order through our online catalogue without restrictions.
• FFF430 is no longer subject to intermittent supply.
• This ICN is now closed.

• The supply issue with Fluid Warming products from KCI Medical Ltd has improved.
• FSB653 and FSB656 are now available to order without restrictions.
• FFF430 remains subject to intermittent supply.
• Three products remain subject to Protect Demand Management:
  • FSB658 – High flow disposable set for Ranger blood and fluid warmer
  • FSB934 – Paediatric / Neonatal disposable set warm fluid aspiration set
  • FVR85003 – Disposable High Flow with 121cm Patient Line.
• Four products are now affected in total.
• FSB934, FVR85003 and FFF430 are consumables linked to KCI’s capital equipment; therefore, alternatives are restricted.
• See our Downloads ▼ section to access the product listing and Information for Clinical Choice (ICC) documents for further information on the affected product codes and potential alternatives.
• The supply issue is now anticipated to be resolved by 3 November 2025.

• We have been informed that the British Standards Institute (BSI) has reinstated the EU CE and UKCA (UK Conformity Assessed) certificates for all the impacted 3M™ Ranger™ Blood/Fluid Warming Disposable Sets.
• As a result, the distribution of these models has resumed for the UK, EU and EFTA (European Free Trade Association) markets.
• Stock of these products continue to arrive into our network, with sufficient inbound stock scheduled to meet ongoing demand.
• Demand management will remain in place until stock levels return to normal for all bar eDirect product FFF430.
• An additional Information for Clinical Choice (ICC) for Blood and Fluid Warming Rapid and High Flow has been added to this ICN and the existing ICC for Standard Flow has been updated.
• See our Useful Links section for instructions to follow when ordering Out of Hours, Urgent or Emergency Deliveries.
• See our Downloads ▼ section to access the product listing and Information for Clinical Choice (ICC) documents for further information on the affected product codes and potential alternatives.
• The supply issue is still anticipated to be resolved by Monday 13 October 2025.

• The inbound stock from KCI Medical is now being received into our network.
• There is enough stock to meet customer demand, however Demand Management will remain in place as we build up national stock levels. We continue to work closely with KCI Medical to achieve this.
• Some systems may still show products as out of stock as they are being updated, however orders will be fulfilled so customers can continue to place orders for these products.
• If you have an urgent clinical need for these products then please follow the escalation process.
• See our Useful Links section for instructions to follow when ordering Out of Hours, Urgent or Emergency Deliveries.
• See our Downloads ▼ section to access the product listing and Information for Clinical Choice (ICC) documents for further information on the affected product codes and potential alternatives.
• The supply issue is now anticipated to be resolved by Monday 13 October 2025.

• The inbound stock from KCI Medical is expected to be received into our network on Thursday 18 and Friday 19 September 2025.  
• Once the stock has been received, the suspension will be lifted. 
• All products will be subject to Protect Demand Management. This will remain in place as we build up national stock levels.  
• See our Useful Links section for instructions to follow when ordering Out of Hours, Urgent or Emergency Deliveries. 
• See our Downloads ▼ section to access the product listing and Information for Clinical Choice (ICC) documents for further information on the affected product codes and potential alternatives. 
• The supply issue is now anticipated to be resolved by Monday 13 October 2025. 

• We continue to engage with KCI Medical Ltd to track the arrival of inbound stock, details of which will be shared in due course.
• NHS England has written to all trusts instructing them on key actions and steps that should be followed. The letter has been added to this ICN. Trusts need to ensure this information is disseminated to all relevant teams.
• To assist with the identification of potential alternatives an Information for Clinical Choice (ICC) Fluid Warming Unit document has also been added to this ICN.
• This is in addition to the existing ICC Blood and Fluid Warming Standard Flow document.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives, the NHS England letter and ICC documents.
• The supply issue is still anticipated to be resolved by 22 September 2025.

• The supply issue with Fluid Warming products from KCI Medical Ltd is continuing.
• A supplier letter has been added to this ICN to advise further context to the regulatory issue.
• The Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Exceptional Use Authorisation (EUA) to enable purchases of further stock, for an initial period of four weeks.
• Following the temporary lifting of restrictions further stock will be shipped by the manufacturer in the coming days.
• One further product code is now unavailable to order:
  • FFF430 – Disposable High Flow with 121cm Patient Line.
• Three product codes are no longer subject to Protect Demand Management and are suspended an unavailable to order:
  • FSB656 – Standard flow disposable set with extension for Ranger blood and fluid warmer.
  • FSB658 – High flow disposable set for Ranger blood and fluid warmer
  • FSB653 – Standard flow disposable set for Ranger blood and fluid warmer.
• Two product codes remain subject to Protect Demand Management:
  • FSB934 – Paediatric / Neonatal disposable set warm fluid aspiration set
  • FVR85003 – Disposable High Flow with 121cm Patient Line.
• FSB653, FSB656, FSB658, FSB934, FVR85003 and FFF430 are consumables linked to KCI’s capital equipment; therefore, alternatives are restricted.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• Once stock has been received, all products will be subject to Protect Demand Management with a 150% threshold on business-as-usual order levels to ensure fair distribution.
• Customers should continue to follow NHS England advice to consider mutual aid, protect existing stock of these products based on clinical priority, and increase use of alternative products, where possible.
• The supply issue is now anticipated to be resolved by 22 September 2025.

• The supply issue with Fluid Warming products from KCI Medical Ltd is continuing.
• A supplier letter has been added to this ICN to advise further context to the regulatory issue.
• Five product codes remain subject to Protect Demand Management:
  • FSB653 – Standard flow disposable set for Ranger blood and fluid warmer.
  • FSB656 – Standard flow disposable set with extension for Ranger blood and fluid warmer.
  • FSB658 – High flow disposable set for Ranger blood and fluid warmer
  • FSB934 – Paediatric / Neonatal disposable set warm fluid aspiration set
  • FVR85003 – Disposable High Flow with 121cm Patient Line.
• Five products remain affected in total.
• The affected products are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure fair supply of available stock across the NHS.
• FSB653, FSB656, FSB658, FSB934 and FVR85003 are consumables linked to KCI’s capital equipment; therefore, alternatives are restricted.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives, as well as the Information for Clinical Choice for Blood and Fluid Warming Standard Flow.
• The supply issue is now anticipated to be resolved by the 30 September 2025.

See our Useful Links section for further information on our Demand Management and Information for Clinical Choice pages.

Change:

• The supplier KCI Medical Ltd has informed us of a supply issue with its Fluid Warming products.
• Five product codes are affected:
  • FSB653 – Standard flow disposable set for Ranger blood and fluid warmer
  • FSB656 – Standard flow disposable set with extension for Ranger blood and fluid warmer
  • FSB658 – High flow disposable set for Ranger blood and fluid warmer
  • FSB934 – Paediatric / Neonatal disposable set warm fluid aspiration set
  • FVR85003 – Disposable High Flow with 121cm Patient Line.
• The supply issue is due to a regulatory body placing products on hold pending review.
• Due to this ongoing supply issue these products are now being threshold managed as they are subject to Protect Demand Management.

Impact:          

• The affected products are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure fair supply of available stock across the NHS.
• FSB653, FSB656, FSB658, FSB934 and FVR85003 are consumables linked to KCI’s capital equipment; therefore, alternatives are restricted.
• 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 22 September 2025.

Next Steps:              

• Customers are advised to log into our website to view the product listing for further information on the affected product codes and website to view the product codes currently subject to Protect Demand Management.
• 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.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

See our Useful Links section for further information on our Demand Management and Information for Clinical Choice pages.