Field Safety Notice Applied Medical Epix® Universal Clip Applicator FGE771 (ICN 2463)

Alert:

• Applied Medical is conducting a Field Safety Corrective Action affecting specific Lot numbers of the Epix® Universal Clip Applier due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.
• The nonconformance does not impact the functionality of the clip when applied to a structure. The clip itself will be properly formed and applied to the structure when the clip is loaded into the jaws of the device.
• As a precautionary measure Applied Medical is recalling all potentially affected units. Please refer to the Field Safety Notice for full detail of all products and Lot numbers.

Products Affected:

•  One of the products affected is available from NHS Supply Chain via our eDirect route:

• Please note only the Lot numbers quoted in the Field Safety Notice are affected.
• Applied Medical has confirmed ten Lot numbers affecting UK customers, as noted in the above table.
• This Field Safety Notice does not impact on product availability.

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.
• Complete the Customer FSCA Notification Confirmation Form, page 3 of the Field Safety Notice and email to: Reply-Europe@appliedmedical.com. Please complete and return this form even if you no longer have
• On receipt of the completed form Applied Medical will contact you to arrange to collect the affected products in your possession.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including NPC, lot numbers and quantity stating whether boxes or eaches. This will enable us to assist you and manage your customer credit where appropriate.

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.