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URGENT FIELD SAFETY NOTICE: RA20192137735Product: LINA Smoke Pencils and LINA Telescopic Smoke Pencils ATTN: Director, Risk Manager, Materials Manager Date FSA identification: Field Safety Corrective
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What is field safety notice?
Field safety notices are documents issued by manufacturers or distributors to inform users of medical devices about potential risks or hazards associated with the product.
Who is required to file field safety notice?
Manufacturers or distributors of medical devices are required to file field safety notices.
How to fill out field safety notice?
Field safety notices can be filled out electronically through the appropriate regulatory authorities' portals or by submitting the required information via mail or email.
What is the purpose of field safety notice?
The purpose of field safety notices is to alert users of medical devices about potential risks or hazards associated with the product and provide guidance on how to mitigate those risks.
What information must be reported on field safety notice?
Field safety notices must include details about the specific risks or hazards, instructions for users on how to mitigate those risks, and contact information for further inquiries or reporting adverse events.
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