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[Recipients Address]February 14, 2019URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Notice for Recall Reference: R201841 Concerned Devices: Modular Head DisimpactorProduct NumberDescriptionBatch
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Gather all necessary information related to the safety notice.
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Clearly identify the urgency level of the safety notice.
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Provide clear instructions on how to address the safety issue.
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Who needs urgent field safety notice?

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Manufacturers or distributors of products that have been deemed potentially hazardous
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Regulatory bodies or authorities responsible for overseeing product safety
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Healthcare professionals or facilities that may come into contact with the product in question
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Urgent Field Safety Notice is a notification issued by manufacturers, distributors, or importers to inform about a product safety concern that requires immediate action.
Manufacturers, distributors, or importers are required to file urgent field safety notices.
Urgent field safety notices should be filled out with information about the safety concern, affected products, actions recommended to be taken, and contact details for further inquiries.
The purpose of urgent field safety notice is to inform about a product safety concern that requires immediate action to prevent harm or injury to the users.
Information such as the safety concern, affected products, recommended actions, and contact details must be reported on urgent field safety notices.
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