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Benton Dickinson France S.A.S. Share capital: 62 823 000 11, rue Aristides Bergs 38800 Le PontdeClaix France T.V.A. FR70 056501711 RCS Grenoble B 056 501 711 SIRET 056 501 711 00115Belgian Branch/Bijkantoor

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What is urgent field safety notice?

A urgent field safety notice is a communication issued by a manufacturer, importer or distributor to inform recipients of a non-conformance with a medical device that could pose a serious risk to the health and safety of patients, users or other persons.

Who is required to file urgent field safety notice?

Manufacturers, importers or distributors of medical devices are required to file urgent field safety notices.

How to fill out urgent field safety notice?

Urgent field safety notices should be filled out with detailed information about the non-conformance, the potential risks, and the actions that need to be taken by recipients.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notices is to alert recipients about potential risks associated with a medical device and provide instructions on how to mitigate those risks.

What information must be reported on urgent field safety notice?

Information that must be reported on urgent field safety notices includes the nature of the non-conformance, the potential risks, the affected devices, and the actions that need to be taken.

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