Field Safety Notice Smiths Medical Jelco IV Catheter Product Recall (ICN 2269)

Alert:

• Smiths Medical, Inc, has identified a potential manufacturing defect within specific Lots of the 24 – gauge Jelco IV Catheters Products.
• The manufacturing defect can potentially create a leak path in the catheter tubing underneath the catheter hub.
• A potential concern would be any fluid loss that would disrupt routine fluid delivery, drug delivery or administration of blood.

Products Affected:

• The Catheters are available on NHS Supply Chain’s Stock Route:

• Please note this device reads MPC 4013-AI in the NHS Supply Chain catalogue.
• NHS Supply Chain’s stock has been checked and all future issues will be of 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 products with the above Lot numbers.
• Complete and return the letter of destruction form even if you do not have affected batch numbers by emailing Emea-Quality@icumed.com
• Contact your NHS Supply Chain Customer Service Advisor with full details of the quantity of affected products in your possession including the Lot numbers, and whether the quantity is in eaches or boxes of 50.
• Your Customer Service Advisor will confirm the details and give you a unique CMS reference number. On receipt of written confirmation of disposal quoting the CMS reference number credit will be raised on your behalf.

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 or 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.