Supply Issues ICU Medical International Limited (formerly Smiths Medical) Bivona® Neonatal Paediatric and Adult Tracheostomy Tubes (ICN 2830)

• The supply issue with Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes products from ICU Medical International Ltd is now resolved.
• FDG261, FDG266, FSM6989, FSM6990 and FSM7024 are now available to order through our online catalogue without restrictions
• This ICN is now closed.

• The supply issue with Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes products from ICU Medical International Ltd is continuing.
• Five products remain subject to Protect Demand Management:
  • FDG261, FDG266, FSM6989, FSM6990 and FSM7024.
• Five products 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.
• The supply issue is now anticipated to be resolved by 6 October 2025.

• The supply issue with Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes products from ICU Medical International Ltd is continuing.
• Five products remain subject to Protect Demand Management:
  • FDG261, FDG266, FSM6989, FSM6990 and FSM7024.
• Five products 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.
• The supply issue is now anticipated to be resolved by 1 September 2025.

• The supply issue with Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes products from ICU Medical International Ltd has improved.
• 101 products are now available to order through our online catalogue.
• Five products remain subject to Protect Demand Management:
  • FDG261, FDG266, FSM6989, FSM6990 and FSM7024.
• Five product codes are now 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.
• The supply issue is now anticipated to be resolved by 31 July 2025.

• The supply issue with Bivona® Neonatal, Paediatric and Adult Tracheostomy Tube products from ICU Medical International Ltd is continuing.
• Two product codes are no longer subject to demand management and are available to order:
  • FDG258 and FDG591.
• Nine product codes remain subject to Protect Demand Management:
  • FDG261, FDG264, FDG266, FSM6989, FSM6990, FSM6991, FSM7024, FSM7030 and FSM7058.
• 97 product codes remain subject to intermittent supply.
• 106 product codes are now affected in total.
• There are potential indirect alternatives for some of the products affected.
• 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.
• The full range of Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes and potential alternatives will remain in the product listing until the supply issues are resolved.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives and for a full list of product codes subject to Protect Demand Management.
• The supply issue is still anticipated to be resolved by 30 June 2025.

Change:

• The supplier ICU Medical International Limited has informed us of a supply issue with its Bivona® Neonatal, Paediatric and Adult Tracheostomy Tubes products.
• 117 product codes are affected in total.
• The supply issues are a result of the Smiths Medical Bivona® Field Safety Notice (FSN), published 14 June 2024.
• See our Useful Links section to view ICN 2569 for further information on the original FSN.

Impact:          

• 97 product codes are currently subject to intermittent supply.
• 11 product codes are currently subject to Protect Demand Management:
  • FDG258, FDG261, FDG264, FDG266, FDG591, FSM6989, FSM6990, FSM6991, FSM7024, FSM7030 and FSM7058.
• Nine affected product codes have now been delisted from our online catalogue:
  • FSM6956, FDG800, FDG801, FSM7036, FSM6986, FSM7037, FSM6987, FSM7038 and FSM7108.
• The demand managed 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:
• There are potential indirect alternatives for some of the products affected. However, some of these products may also be subject to intermittent supply.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives and for a full list of product codes subject to Protect Demand Management.
• The supply issue is anticipated to be resolved by 30 June 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 potential alternatives and 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.
• 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.
• 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.