Field Safety Notice Masimo TC-1 Reusable Tip Clip Sensor Product Recall – Specific Lot Numbers Only (ICN 2181)

Alert:

• Masimo has issued following identifying that some lot numbers of the TC- I Reusable Tip Clip sensors have a higher-than-expected variability in SpO2 readings that are outside of the accuracy specification. Masimo’s investigation found the TC-I sensors had higher variability with an overall Arms of 4.4% compared to the specification of 3.5% Arms.
• Inaccurate readings could potentially result in a delay in care or unnecessary medical intervention.
• Masimo advise they have not received any complaints alleging adverse events.
• The Field Safety Notice applies only to the specific TC-I Reusable Tip Clip Sensor with the part and lot number(s) identified.

Products Affected:

•  Two the products affected have been supplied via NHS Supply Chain:

• Please note the affected lot numbers were supplied during 2018 – 2019.
• FBC316 was delisted in 2019.
• Masimo advise there is no impact to any other Masimo product.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice PDF and share with all users of the affected products.
• Assess your inventory, cease use, and quarantine all sensors with the part numbers and lot numbers listed in attachment two of the customer notice.
• Please note the part and lot number quoted are the total supplied via NHS Supply Chain, not to your organisation.
• Complete attachment 1, then email it to CustomerNotice@masimo.com, or fax it to 1-949-297-7575 as soon as possible.
• Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/or if you have part numbers or lot numbers not included in this communication and have questions about those parts. Masimo’s Technical Services is available Monday through Friday 6:00am – 5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com.
• Contact your local NHS supply Chain Customer Service Advisor with full details of all affected products in your possession to enable us to maintain our records and assist, as necessary.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK Responsible Persons and Distributors 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.