Field Safety Notice Polyflush Pre-filled Syringes (ICN 2143)

Alert:

• Poly Medicure Ltd, via distributor GBUK Limited, has issued a Field Safety Notice for its Polyflush Syringe, 0.9% Sodium chloride (0.9% NaCl), Saline Solution Pre-Filled Syringe-10ml Single Sterile.
• There is a potential risk of the use of empty syringes (i.e., without saline).
• The Field Safety Notice is issued to mitigate the risk of using an empty syringe by ensuring the instructions for use are followed.
• Patients are at risk of being accidentally injected intravenously with air.

Products Affected:

•  This product is available from NHS Supply Chain stock:

• Please note only the batch number quoted in the Field Safety Notice is affected.
• NHS Supply Chain confirms there are no affected batches in our warehouses, all devices being distributed are of different, non-affected batches.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.

Safety information in Instructions for use:

1. Open the pack and remove the syringe
2. Visually inspect the product for particulate matter and discolouration prior to use according to warning and precautions
3. Check that the syringe tip cap is in place. Inspect the clarity of the solution visually
4. Depress the plunger with the tip cap to release the stopper seal
5. Push the syringe plunger to expel the air.

Do not use devices if no solution is observed when expelling the air.

• Presence of saline solution can be seen visually when the user checks the clarity of the solution and push the syringe plunger to expel the air. During this activity, such devices are immediately identified and not to be used.
• Complete and return Annex 1 Customer Response Form to info@polymedicure.com as soon as possible.
• Should you have concerns about effectively removing these syringes from critical areas and believe continued use might pose a significant risk to your trust, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 8, not to specification).
• Please confirm if the quantity of product to be returned is in the unit of issue, for example, a box of 10 or is it in singles. Please also provide batch numbers.
• All products are to be returned no later than Friday 24 June 2023.
• Where potential alternatives are identified, customers are advised to consult their 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.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons and distributors 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.