Field Safety Notice Intersurgical Spirometry Sets and Anaesthetic Breathing Systems Containing Spirometry Sets (ICN 3522)

NHSSC: 77

Alert:

• Intersurgical has issued a Field Safety Notice regarding specific Lots of spirometry sets and anaesthetic breathing systems containing spirometry sets.
• The supplier received reports from the market of abnormal waveform performance and inaccurate physiological measurements.
• In response to the reports, Intersurgical’s investigation identified limitations in the existing internal test protocol that may not reliably detect certain assembly and functional defects.
• The identified defects are not expected to compromise patient ventilation or oxygenation. However, they may result in inaccurate physiological values and abnormal waveform displays.

Products Affected:

• 12 products are affected.
• Five of the affected products are available through NHS Supply Chain’s stocked and eDirect routes.
• See our Downloads ▼ sections to access the product listing and Field Safety Notice for further information on the affected product codes.
• Please note only the Lots listed on page 3 of the notice are affected.
• All NHS Supply Chain’s stock has been checked and affected products quarantined.
• The supplier has advised this recall does not impact future supply of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Complete the customer response form, found on page 8 of the notice, and return to priority@intersurgical.co.uk detailing any affected product identified and to be destroyed.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including national product code (NPC), Lot numbers and quantity. Your Customer Service Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Service Advisor will raise the appropriate credit.

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.