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URGENT Field Safety Notice Vitré Directory fluid/gas handling Instrument Vitré Ophthalmic infusion/aspiration cannula, single use Voluntary recall of affected lots December 06, 2019, Dear Customer,
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Determine the urgency level of the safety notice based on the severity of the safety issue.
02
Gather all relevant information about the safety issue, including product details, affected batch numbers, and any reported incidents.
03
Draft a clear and concise safety notice, including instructions for distributors, retailers, and consumers on how to respond to the issue.
04
Include contact information for recipients to report any further incidents or seek clarification.
05
Distribute the safety notice promptly through appropriate channels to ensure maximum reach and effectiveness.
06
Follow up with recipients to ensure compliance and address any additional concerns or questions.
Who needs urgent field safety notice?
01
Manufacturers
02
Distributors
03
Retailers
04
Consumers
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What is urgent field safety notice?
It is a communication tool used to inform users and healthcare professionals about a safety concern related to a medical device.
Who is required to file urgent field safety notice?
Manufacturers, importers, and distributors of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
The urgent field safety notice must be filled out with detailed information about the safety concern, affected device, potential risks, and recommended actions.
What is the purpose of urgent field safety notice?
The purpose is to inform users and healthcare professionals about potential safety concerns related to a medical device and to recommend necessary actions to address these concerns.
What information must be reported on urgent field safety notice?
The notice must include information about the safety concern, affected device models, potential risks to users, and actions required to mitigate these risks.
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