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Cookbook Medical Europe OHalloran Road, National Technological Park, Limerick, Ireland. Phone: + 353 61 334440Urgent Field Safety Notice: + 353 61 334441Commercial name of the affected product: Furman
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Begin by entering the required contact information for the person responsible for the notice.
02
Fill in the details of the urgent field safety notice, including the product name, model number, and a description of the safety issue.
03
Clearly outline the actions that need to be taken by the recipient, such as stopping product use or contacting the manufacturer for a replacement.
04
Provide clear instructions on how to return the product or take necessary safety precautions.
05
Include a deadline for compliance and contact information for any further questions or concerns.
Who needs urgent field safety notice?
01
Manufacturers, distributors, or retailers who have identified a safety issue with their product that requires immediate action to prevent harm to consumers.
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What is urgent field safety notice?
Urgent field safety notice is a notification issued by a manufacturer, distributor, or importer of a medical device to inform users about potential safety issues that require immediate attention.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and importers of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices can be filled out online through regulatory authorities' portals or submitted directly to the authorities in the required format.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to inform users about potential safety issues with a medical device and provide instructions on how to mitigate the risks.
What information must be reported on urgent field safety notice?
Urgent field safety notices must include details about the safety issue, affected product details, potential hazards, instructions for users, and contact information for reporting adverse events.
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