Field Safety Notice ICU Medical CADD™ Medication Cassette Reservoirs (ICN 3077)

NHSSC: 66

Alert:

• ICU Medical has issued a Field Safety Notice regarding a potential issue with specific models and Lots of 50ml and 100ml CADD Medication Cassette Reservoirs.
• Certain CADD 50ml and 100ml Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
• Leakage from a weakened medication bag weld could potentially result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
• ICU Medical advise they have received no reports of serious injuries or deaths as a result of this issue.

Products Affected:

• Five of the affected products are available via NHS Supply Chain. Please refer to the product listing for full details.
• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• NHS Supply Chain stock has been checked with no affected products found.
• Future orders will be fulfilled with unaffected, different Lot numbers.

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 products with the affected Lot numbers.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including 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 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.