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VOLUNTARY FIELD SAFETY NOTICE ACKNOWLEDGEMENT FORM CARTOON Module in conjunction with SOUND STAR eco 8F and eco 10F CathetersCatalog No: C3SOUND, 10439236, 10439072, 10439011 & 10438577 The purpose
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Gather all necessary information about the safety issue.
02
Complete the Urgent Field Safety Notice form with detailed information about the issue.
03
Clearly explain the potential risks and hazards associated with the safety issue.
04
Include instructions for how to mitigate or resolve the issue.
05
Provide contact information for any questions or concerns about the notice.

Who needs urgent field safety notice?

01
Companies or organizations who have identified a safety issue with their products or services that require urgent attention.
02
Customers or users who may be affected by the safety issue and need to be informed promptly.
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An urgent field safety notice is a notification issued by manufacturers or regulatory authorities to inform healthcare professionals and users about a potential safety issue with a medical device or product that requires immediate action.
The manufacturer or authorized representative of the medical device or product is required to file an urgent field safety notice.
To fill out an urgent field safety notice, provide details such as the product name, description of the issue, actions to be taken, affected lots or batches, and contact information for follow-up questions.
The purpose of an urgent field safety notice is to communicate risks associated with a medical device or product and to ensure the safety of patients and users by prompt corrective action.
The urgent field safety notice must report information including product identification, risk description, affected batches or serial numbers, recommended actions, and contact details for further inquiries.
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