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FSN Ref: Anika ref numbers Ref: Anika ref numerate: [] May 2021URGENT FIELD SAFETY NOTICE
POTENTIAL STERILIZATION RISK
HALOCLINE ANTIADHESION GEL/ HYALOBARRIER GEL/
HYALOBARRIER GEL END
PRODUCT DESTRUCTION
For
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What is urgent field safety notice?
Urgent field safety notices are notifications issued by manufacturers or distributors to inform users of a medical device about a potential safety issue that requires immediate attention.
Who is required to file urgent field safety notice?
Manufacturers or distributors of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices are typically filled out by providing details about the safety issue, affected products, and recommended actions for users.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to alert users of a medical device about potential safety issues and provide guidance on how to address them.
What information must be reported on urgent field safety notice?
Information that must be reported on urgent field safety notice includes details about the safety issue, affected products, recommended actions, and contact information for further assistance.
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