Field Safety Notice Philips Microstream Intubated Filter Lines (ICN 2929)
Important Customer Notice Status New Type Product Alert
NHSSC: 08
Alert:
- Philips has issued a Field Safety Notice: 2025-CC-HPM-011, updating the instructions for use, (IFU), for the Microstream Advance Intubated CO2 Filter Line, VitaLine Intubated CO2 Filter Line and FilterLine Intubated CO2 Filter Line.
- The IFU addendum is being issued to address customer reports of difficulty or inability to disconnect an adapter from a patient’s endotracheal tube in order to perform a procedure.
- The addendum includes information on potential adverse events that may result from a failure to follow instructions for safe use of the airway adapter, as originally stated in the IFU.
- The inability to, or difficulty in disconnecting the adapter from the endotracheal tube to perform a procedure such as suctioning or administration of airway medication can result in an unintended extubation to perform the required procedure and/or a delay of treatment.
Products Affected:
- Eight of the products affected are available from NHS Supply Chain.
- See our Downloads ▼ section to access the product listing for further information on the affected product codes.
Next Steps:
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Complete the Response Form, found on page 5 of the Field Safety Notice and return to: UKI_Quality_CR@philips.com
- If you need any further information or support concerning this issue, please contact your local Philips representative at the Philips Customer Care Service Centre – Telephone: +448000260086.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care 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.