Product Recall Smiths Medical Nasopharyngeal Airway Double Swivel Connector 15mm Y Piece Portex™ Orator Speaking Valve Thermovent™ 1200 (ICN 2688)

MHRA TBC

NHSSC Ref: 52

Alert:

• Smith Medical has issued a Field Safety Notice having identified a potential issue with the packaging sterile seals on specific Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, Thermovent™ 1200 products packaged between 20 January 2021 and 27 August 2021.
• Where there is uncertainty around the integrity of a packaging seal the sterility of the product may be compromised, and there is a potential risk of infection if used.

Products Affected:

•  Four of the products affected have been supplied by NHS Supply Chain:

• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• Where products are stocked at NHS Supply Chain warehouses all future deliveries will be of different, unaffected Lot numbers.
• This withdrawal should have no impact on future availability.

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 Lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products in your possession, including NPC, Lot numbers and quantity stating whether in the unit of issue box quantity or eaches.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

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.