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URGENT FIELD SAFETY NOTICE MICROPLATE plasma filters March 2018 Medtronic Reference: FA807Attention: Risk Management Director, Safety Officer, OR and ICU Materials Management, ICU Medical Directors
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What is urgent field safety notice?
Urgent field safety notice is a notification that must be issued to inform about a safety concern regarding 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, actions taken, and contact details.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to ensure the safety of patients and users of medical devices.
What information must be reported on urgent field safety notice?
Information such as the identified safety issue, affected medical devices, actions taken, and contact details must be reported on urgent field safety notice.
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