Product Recall Smiths Medical BLUSelect™ Pilot Balloon Detachment (ICN 2645)

Alert:

• Smiths Medical has issued an Urgent Field Safety Notice having identified a manufacturing defect with the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific Lots of the BLUSelect®, BLUgriggs® and BLUperc® products.
• If the pilot balloon used to inflate the tracheostomy cuff becomes detached from the inflation line, the cuff pressure may not be maintained which can lead to inadequate ventilation of, and increased risk of aspiration to the patient.
• Smiths Medical advise, to date, they have received thirteen (13) reports of serious injury and zero (0) deaths associated with this issue.

Products Affected:

• 39 of the affected products are available from NHS Supply Chain on our eDirect service, 11 are stocked lines. Please refer to the product listing for full details.
• NHS Supply Chain warehouse stock is being checked and future issues of these products will be of unaffected Lot numbers.
• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• An update will be issued as soon as Smiths Medical are able to confirm estimated dates for resumption of supply.

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 affected Lot numbers.
• Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products in your possession, including NPC, Lot numbers and quantity stating whether boxes 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.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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.