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URGENT FIELD SAFETY NOTICE: RA2016193
Stryker Smartie Large Aseptic Housings
ATTN: RISK MANAGER, OR DIRECTOR, MATERIALS MANAGER
March 16, 2017,
FSA Identifier: RA2016193
Type of Action: Field Safety
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What is urgent field safety notice?
Urgent Field Safety Notice is a notification issued to inform users of a medical device about a potential safety issue that requires immediate action.
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 issue, affected devices, recommended actions, 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 by providing necessary information about potential risks and recommended actions.
What information must be reported on urgent field safety notice?
Information such as the nature of the safety issue, affected device model numbers, recommended actions for users, and contact information for reporting issues must be reported on urgent field safety notices.
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