Field Safety Notice Nihon Kohden Recording Paper (ICN 2757)

MHRA TBC

NHSSC: 78

Alert:

• Nihon Kohden has issued a Field Safety Corrective Action for its Recording Paper models NKUK-A054 and NKUK-MLSC-125 for Electrocardiographs due to incorrect labelling.
• It has been determined that the recording papers do not meet the regulatory requirements for the labelling of medical devices. However, there is no restriction in the intended use, technical specification, manufacture, function, performance of safety of the recording papers.
• The non-conformity relates exclusively to the labelling.
• NIHON KOHDEN UK Ltd falsely marketed the recording paper under its own name, although is not the actual manufacturer of the recording paper.
• The company Nissha Medical Technologies Ltd is the actual manufacturer of the recording paper.
• There is no risk to patients or operators or for documenting/archiving purposes if the incorrectly labelled recording paper is used.

Products Affected:

• The affected products were marketed incorrectly from April 2020 and were available from NHS Supply Chain as:

•  These products are no longer available to order from NHS Supply Chain and are deactivated.
• Existing stocks of incorrectly labelled recording paper can be continued to be used.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Nihon Kohden advise continued use of the product following the information in the FSN.
• This is not a product recall, and no return of product is required.

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.