Field Safety Notice Masimo NomoLine Cannulae and Procedural Oxygen Masks (POM) Masks Kits FBC3594 (ICN 3447)

• Masimo has issued a Field Safety Notice having identified a packing error with specific lots of NomoLine cannulae and NomoLine POM mask kits.
• NomoLine Cannulas:
  • Specific lots of NomoLine Cannulas were found to have been packaged with equivalent products with a different connector type than was ordered or labelled on the packaging, causing an inability to use the cannulas due to the connector incompatibility.
• NomoLine POM Mask Kits:
  • Specific lots of NomoLine POM Masks were found to have been packaged with the wrong size POM masks. Customers who ordered Adult NomoLine POM Mask kits may have received paediatric POM masks in the kit packaging. Due to the size difference in the mask, the mask will not fit properly on adults. The discrepancy is visually detectable.
• Masimo advises there is no adverse health consequences associated with this issue as the discrepancies either incompatibility issue or a detectable size difference that would prevent them from being used.
• Masimo also advises the likelihood of receiving the affected products is low, with a limited number of customer complaints to date.
• In addition, Masimo has conducted a thorough inventory review.

Products Affected:

• There are four products affected.
• One of products affected is available via NHS Supply Chain’s eDirect Service:

• Please note only Lot number 25H32 quoted in the Field Safety Notice and above is affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Check the packaging of the specified parts and Lot numbers for the NomoLine Cannulas and NomoLine POM Masks and ensure that the received cannulas and masks align with the ordered part and package labelling.
• If you identify a NomoLine Cannula or NomoLine POM Mask Kit that has been mispackaged, contact Masimo Technical Services: TechService-IT@masimo.com to request return of the affected part and Lot numbers for replacement.
• Please also complete the response form at the bottom of Attachment 1 and return to CustomerNotice@masimo.com no later than 3 September 2026.

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.