Supply Issues Becton Dickinson Alaris™ VP Infusion Sets (ICN 3244)

Situation overview:

• Becton Dickinson (BD) UK Ltd has issued a Field Safety Notice for specific lots of its Alaris™ VP Infusion Sets.
• BD has identified, due to a manufacturing issue within a supplier sub-assembly, that specific lots of Alaris™ VP Infusion Sets have the potential for fluid leakage from the silicone tube at the end of the pumping segment.
• Leakage could result in:
  • Under infusion of therapy
  • Potential exposure to hazardous drugs
  • Increased risk of air embolism or bacterial contamination
  • Treatment delay, interruption or infection risk.
• Affected stock is being recalled as a precautionary measure. BD reports no serious adverse events to date.
• All affected stocked lines at NHS Supply Chain have been quarantined.
• Eight product codes are affected:
  • Stocked lines – FKA867, FKA883, FKA868, FKA879
  • eDirect lines – FSB2534, FKA876, FSB8564, FKA882.
• Two stocked lines are suspended and unavailable to order:
  • FKA867 and FKA868.

Impact:

• The four stocked lines are available to order through NHS Supply Chain but are subject to Protect Demand Management and are being threshold managed. Trusts are allocated a maximum daily quantity or “threshold” to ensure fair supply of available stock across the NHS.
• We are working closely with BD and are awaiting further information on future inbound supply for stocked lines and the supply position for eDirect lines.
• Indirect alternative pump sets are available to order through our online catalogue but are limited to products within this same range.
• The supply disruption is anticipated to be resolved by 20 March 2026.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products. See our Useful Links ▼ section to read the full Field Safety Notice (ICN 3235) which relates to this ICN.
• The 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.
• BD is suggesting a non-dedicated alternative could be used, however, using these products would require careful consideration and agreement at a trust level with the clinical team before changing current practice.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

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.