Field Safety Notice ICU Medical IV Tubing Set Drip Chambers (ICN 3463)

NHSSC: 51

Alert:

• ICU Medical has issued Field Safety Notice regarding reports of discolouration have been received concerning the drip chambers of certain IV sets.
• ICU Medical has completed its investigation of reported discolouration observed in certain IV tubing set drip chambers.
• The investigation confirmed that the observed discolouration is characteristic of the drip chamber material, does not enter the fluid path, and does not affect device safety, performance, or intended use.
• Based on these findings, products should continue to be used as intended and per facility protocol.
• Please review the Field Safety Notice for full details on ICU Medical’s investigations.

Products Affected:

• All ICU Medical IV tubing sets with a drip chamber that are within their expiration date are covered by this Field Safety Notice, including Plum administration sets with drip chambers, IV non-dedicated gravity administration sets with drip chambers, IV sets with drip chambers and oncology sets with drip chambers.
• 11 of the products affected are available via NHS Supply Chain eDirect route.
• See our Downloads section to access the product listing for further information on the affected product codes.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete ICU Medical’s Response Form found page 4 of the notice and return to: EMEA-FSN@icumed.com.
• ICU Medical’s completed investigation supports continued use of products in accordance with their intended use and standard clinical practices.
• Healthcare providers should therefore continue using products in accordance with the instructions for use and established clinical procedures per facility protocol.
• No product returns are necessary.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute 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.