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003364610/06/2019DGDMFMDSA Allegato Tenth 3 (A03)URGENT FIELD SAFETY NOTICE FCA # 132 Product: Retroflex Introducers Model Number: I355BF9 Lot Numbers: 61409005, 61409006, 61417169, 61446317, 61446318,
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Gather all necessary information related to the safety notice.
02
Clearly outline the urgency of the situation in the notice.
03
Include detailed instructions on how to address the safety issue.
04
Specify any required actions or responses from the recipients.
05
Provide contact information for any follow-up questions or concerns.
Who needs urgent field safety notice?
01
Manufacturers
02
Distributors
03
Healthcare providers
04
Consumers or end-users
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What is urgent field safety notice?
Urgent field safety notice is a communication issued to inform users and stakeholders about serious safety concerns or hazards related to a medical device.
Who is required to file urgent field safety notice?
Manufacturers, authorized representatives, and distributors 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 safety concern, affected devices, actions to be taken, and contact information.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to ensure the safety of users and patients by addressing and resolving potential risks associated with a medical device.
What information must be reported on urgent field safety notice?
Information such as the nature of the safety concern, affected device models, actions recommended by the manufacturer, and contact details for further inquiries must be reported on urgent field safety notice.
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