Field Safety Notice Bonree Medical Distributed by GenX Medical Open Suction Catheters (ICN 2306)

Alert:

• Bonree Medical who manufactures a range of suction catheters supplied by GenX Medical has issued a Field Safety Notice BR230418.
• Due to the potential for catheters to shrink after extrusion during production, this can lead to incorrect marking on the product. Therefore, the length of the suction tube is different from that indicated on the product and the “centimetre” mark on each tube is located at a different location on each tube.
• This could cause the user to enter the catheter too far or not enough during the suction process.
• If the suction catheter is longer than indicated by the markings this may cause unintended contact with the patient’s airway and over time this can lead to granuloma.

Products Affected:

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

• Please note only the Lot number quoted in the Field Safety Notice is affected.
• These products were previously supplied via the Blue Diamond route with the now delisted product codes, FSQ3034, FSQ2929, FSQ2825 and FSQ2931.
• Due to the quarantining of the affected Lot number, NHS Supply Chain warehouses are currently out of stock of these catheters. Please refer to ICN 2081 for updates on availability and additional potential alternatives.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Bonree Medical recommend a risk assessment is conducted before use of the affected products.
• Due to the potential inaccuracy of the product length marking, users should not rely solely on the length marking for clinical care. If your organisation’s decision is to not use the affected products:
• Cease use of the affected Lot number and follow the steps below.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of all affected products including product codes, Lot number and quantity, stating whether boxes or eaches.
• Your NHS Supply Chain Customer Service Advisor will arrange a return for credit using reason code 8 “Not to Specification”.
• All products are to be returned no later than Friday 1 December 2023.
• 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.