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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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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.
Manufacturers or distributors of medical devices are required to file field safety notices.
Field safety notices can be filled out electronically through the appropriate regulatory authorities' portals or by submitting the required information via mail or email.
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.
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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