Product Recall Smiths Medical CADD™ Medication Cassette Reservoirs (ICN 2662)

MHRA TBC

NHSSC Ref: 44

Alert:

• Smiths Medical has issued a Field Safety Notice following discovery of a potential issue with specific models and Lot numbers of the 50 ml and 100 ml CADD Medication Cassette Reservoirs.
• Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage at or near the medication bag to tubing joint weld.
• Leakage from a weakened weld at the medication bag to tubing joint could potentially result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

Products Affected:

• Four of the products affected are available from NHS Supply Chain, please refer to the attached product listing for full details.
• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• Smiths Medical advise this recall should have no impact on future supplies.
• Where products are held in NHS Supply Chain warehouses, stock has been checked and all future deliveries will be of different, unaffected 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 affected Lot numbers.
• Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products in your possession, including if the quantity is in the unit of issue or eaches.
• Your Customer Service advisor will confirm details and provide you with a unique CMS reference.
• Dispose of the affected products in accordance with your local regulations.
• On receipt of written confirmation, quoting your unique reference number, credit for the full value of product destroyed will be raised.

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.