Field Safety Notice Fannin Skintact® Defibrillation Electrodes (ICN 3426)

NHSSC: 40

Alert:

• Fannin, the UK distributor for Skintact® defibrillation electrodes, has issued a Field Safety Notice supporting Field Safety Notice RKL- 7048/ RKL- 7079 issued by the manufacturer Leonhard Lang GmbH.
• Due to a manufacturing issue, the connector cannot be fully inserted into the compatible adapter cable using the usual amount of force. The locking tab does not engage and the auditable “click” is absent.
• The manufacturer advises the electrical contact and retention force meet the requirements; safety and performance are not impaired, and the intended use is possible. However, the locking tab not engaging may confuse users and delay treatment.

Products Affected:

• Two products are affected.
• The two products affected are available via NHS Supply Chain.
• However, Fannin UK confirms that the lot numbers listed in the Field Safety Notice for FDK049 (Manufacturer’s Product Code DF30G) have not been supplied to NHS Supply Chain:

• Please note that only the lot numbers quoted on pages 1 and 2 of the Field Safety Notice are affected.
• FDK049 is not affected for NHS Supply Chain customers.
• The supplier is labelling affected product drawing attention to the Field Safety Notice.
• We are expecting a delivery of stock early next week, at which point the FDK317 will be placed on Control Demand Management and customers will need to contact their NHS Supply Chain Customer Service Advisor to place an order.
• Our advisors will ensure that customers are aware that the order placed will be fulfilled with stock affected by this Field Safety Notice and the auditable “click” upon engagement may be absent.
• Fannin is expecting to supply unaffected stock towards the end of August 2026. Upon receipt, Control Demand Management will be removed.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Please note that this is not a product withdrawal or recall. This Field Safety Notice is being issued for information and awareness only, and no further action is required.
• The manufacturer of these pads advises they continue to work as intended and that users simply need to be aware of the change in how the connection is confirmed.
• Leonhard Lang also advise the manufacturing error has been identified and addressed, and a reliable detection method has been implemented.
• 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.