Product Update GenX Open Suction Catheters (ICN 2966)

• We advised customers on the 30 May 2025 to quarantine four Open Suction Catheters supplied by GenX whilst we explore a potential issue.
• This decision has been made based on product safety complaints received by NHS Supply Chain.
• No further orders of the products quarantined will be dispatched until the completion of our investigation.
• Please note the supplier has not issued a Field Safety Notice. This ICN is to advise customers of NHS Supply Chains actions.
• The supply issue with GENX Open Suction Catheters is continuing. We are currently awaiting further investigation results from the Medicines and Healthcare products Regulatory Agency (MHRA). MHRA are working with the manufacturer to determine corrective action post investigation.
• Four product codes remain affected in total:

• The affected product codes remain suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We do not currently have a resolution date for the supply issue and will update this ICN as soon as we have further information.
• Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.

NHSSC: 32

Alert:

• NHS Supply Chain has made the decision to quarantine four Open Suction Catheters supplied by GenX whilst we explore a potential issue.
• This decision has been made based on product safety complaints received by NHS Supply Chain.
• No further orders of the products quarantined will be dispatched until the completion of our investigation.
• Please note the supplier has not a issued Field Safety Notice. This ICN is to advise customers of NHS Supply Chains actions.

Products Affected:

• There are four stocked products affected:

• These products are currently suspended from our catalogue and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue:
• Please see the attached product listing for more information on the products affected and potential alternatives.

Next Steps:

• Customers who have stock of these products may continue using them if they have experienced no issues.
• However, if any product concerns arise, please notify NHS Supply Chain via our product complaints route. Alternatively, you may choose to quarantine the stock and arrange for its return.
• If you wish to return the product, please contact your local NHS Supply Chain Customer Service Advisor with full details of affected products. Returns should be processed using reason code 8 – (Not for Specification), with all goods returned no later than Friday 20 June 2025.
• Customers are advised to log into our website to access the product listing and the product comparison matrix.
• The product comparison matrix is a tool to support local clinical decision making and to show the range and specification of Suction Catheters available from NHS Supply Chain.
• 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.