Product Recall Intersurgical Ltd Various Uniflow Coaxial Breathing Systems Risk of Disconnection (ICN 2824)

NHSSC: 89

Alert:

• Intersurgical Ltd has issued a Field Safety Notice following reports of the extendable expiratory gas tubing disconnecting from the T- piece, due to insecure connection of the two main parts.
• If the insecure connection of the expiratory gas tube is not identified during set-up and pre-use checks, detachment in use could result in gross leakage and reduced circulating gas volume which would have a negative impact upon ventilation.
• Intersurgical advise the risks associated with the identified fault have been reviewed, and if the fault of potential disconnection is not identified before use, it could result in failure of ventilation and accumulation of Carbon Dioxide, hypercapnia could result in respiratory and metabolic acidosis. If acidosis is left untreated it can lead to organ failure, shock, and death.

Products Affected:

• Please refer to the product listing for full details of the products affected which are available from NHS Supply Chain.
• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• Intersurgical does not anticipate any impact on supplies due to this recall.
• Future orders will be fulfilled with unaffected stock.

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.
• If you have any potentially affected products/ Lot numbers listed in the Field Safety Notice, detail the quantities for each product and Lot number in the Reply Form, page 8 of the notice, and email to: priority@intersurgical.co.uk
• On receipt of the completed Reply Form Intersurgical will contact you to arrange either replacements or agree credit.
• If there is an immediate need to use any of the affected codes/ Lot numbers listed in the note, users should follow the instructions provided on page 3 of the FSN, to check the product for loose expiratory tubes before use.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including product code, Lot numbers and quantity stating whether in box quantity or eaches to enable us to help and where appropriate raise your customer 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.