Field Safety Notice ICU Medical CADD™ Medication Cassette Reservoirs with NRFit (ICN 3473)

NHSSC: 58

Alert:

• ICU Medical has issued a Field Safety Notice regarding a potential issue with specific models and Lots of the 100mL and 250mL CADD Medication Cassette Reservoirs with NRFit Connectors.
• Certain reservoirs may exhibit fluid leakage at the joint between the connector and the tubing.
• Leakage from the joint between the connector and the tubing could potentially result in the delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or an air embolus.

Products Affected:

• Two products are affected.
• The two products affected are available via NHS Supply Chain’s eDirect service:

• Only the Lot numbers noted above and in Table 1 of the Field Safety Notice are affected.
• The supplier has advised 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 the affected lot numbers.
• Complete the Customer Response Form, found in page 3 of the Field Safety Notice, and return to EMEA-FSN@icumed.com
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including national product code (NPC), Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.
• 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.