Field Safety Notice CODAN Invasive Pressure Monitoring Sets with Xtrans or DPT-6000 with Flushing System 3 ml/h (ICN 3546)

NHSSC: 85

Alert:

• CODAN has issued Field Safety Corrective Action Notice FSCA_26-09-098 to request all users follow the instructions set out in point 3, page 3 of the notice, and section 9 extracted from the Instructions for Use (IFU), when using invasive pressure monitoring sets.
• This safety notice applies to all sets fitted with Xtrans® and DPT-6000 series pressure transducers with a 3 ml/h flushing system, which have a date of manufacture between March and August 2026.
• A manufacturing fault during the assembly of the flushing system may result in an increased flushing rate.
• If the user fails to notice the increased flushing rate when setting up the pressure monitoring set, this may result in an overdose of the flushing solution used.

Products Affected:

• 12 products are affected.
• The 12 products affected are available via NHS Supply Chain’s eDirect route.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.

Next Steps:

• Read, share and follow the full instructions in the Field Safety Corrective Action Notice with all the affected users.
• When commissioning a pressure monitoring set, it is essential to observe the following, as stated in section 9 of the supplement IFU:
  • If the fluid does not flow freely during flushing or an increased flow rate is observed after flushing, the pressure monitoring set is not functioning properly and must not be used.
  • A continuous flow of approximately 3 ml/h at 300 mmHg should be observed in the drip chamber.
  • When using a microdrip chamber, the drop rate should be approximately 3 drops per minute.
  • When using a macrodrip chamber, the drop rate should be approximately 1 drop per minute.
  • An excessively high flow rate may result in an overdose of the flushing solution used.
  • Ensure that the pressure in the connected saline bag does not exceed 300 mmHg, as excessive pressure may result in an excessively high flow rate and consequent fluid overload, which may cause a potentially harmful increase in blood pressure.
  • Depending on the patient’s weight, age and overall condition, infusion volume may need to be limited in accordance with the clinical protocols of the responsible organisation.
• See our Downloads ▼ section to view the supplement IFU.
• This note must always be observed, but particularly in the case of pressure monitoring sets manufactured between 2 March 2026 and 31 August 2026.
• See out Useful Links section to view CODAN’s IFUs.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.