Device safety informationMHRA
Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe safety warning over a safety concern
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
What to do now
Users of Aurum pre-filled syringes phased introduction of new 10ml CONNECT are asked to act on new safety information.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/02). Quoted as issued.
Summary
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
The risk
Update: 22 August 2025 We have issued a minor update to this Device Safety Information to remove the reference to the Naloxone pre-filled syringe as this product, which uses a 2 ml barrel, is not affected by the 10ml CONNECT introduction. All other content remains unchanged. Summary
Advice for healthcare professionals
The use of incompatible needle-free connectors (NFCs) with Aurum pre-filled syringes has led to adverse incidents in emergency situations. Attaching an incompatible NFC can block the syringe and prevent delivery of emergency medicine.
A new 10ml barrel design for the Aurum pre-filled syringes, CONNECT, will be compatible with a wider range of NFCs to minimise the occurrence of these adverse incidents. For the transition period, both the new syringe and the established syringe will be available for affected products.
The CONNECT syringe will be introduced to the market in a phased manner. The 10ml CONNECT barrel for the Adrenaline 1:10,000 pre-filled syringe is scheduled for market introduction in July 2025. This will be followed by the phased rollout of the 10ml CONNECT barrel for the Amiodarone and Calcium Chloride pre-filled syringe products.
All NFCs compatible with the established syringe design remain compatible with the CONNECT syringe design. However, the reverse is not applicable. Therefore, during the transition period, until March 2028, there remains an increased risk of inadvertently using an incorrect NFC.
Healthcare professionals should refer to the list of compatible NFCs under the product information listings below which can be used with both designs of the Aurum pre-filled syringes to eliminate the risk of NFC incompatibility during the transition period. This can also be viewed by scanning or clicking the below QR code:
Adrenaline (Epinephrine) Injection 1:10,000
Amiodarone
Calcium Chloride
refer to the list of compatible needle-free connectors (NFCs) under the product information listings (see summary section above) for the Aurum pre-filled syringes, and procure compatible NFCs for use with the established and/or new CONNECT syringe barrel
ensure that the specification of NFCs which are integral to vascular access devices are checked for compatibility before procuring or putting into use in areas where Aurum pre-filled syringes may be used
refer to the compatibility warnings and Luer size limits in the instructions for use of the NFC
train administration and emergency teams and ensure procedures are in place to determine the compatibility of NFCs with the Aurum pre-filled syringes
Advice for patients
there is no related advice for healthcare professionals to provide to patients
Open the MHRA notice
Questions
Why has Aurum pre-filled syringes phased introduction of new 10ml CONNECT been recalled?
Users of Aurum pre-filled syringes phased introduction of new 10ml CONNECT are asked to act on new safety information. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.