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[Recipients Address]February 21, 2019URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Notice for Recall Reference: R201901 Concerned Devices: Smart Stitch PerfectPasser Connector ProductDescriptionBatch
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01
Gather all necessary information such as product details, issue description, affected batch numbers, date of discovery, and potential hazards.
02
Draft a clear and concise notice detailing the issue and the necessary actions to be taken by the recipients.
03
Ensure that the urgency of the notice is clearly communicated and that recipients understand the potential risks involved.
04
Distribute the notice to the relevant parties promptly via email, mail, or other communication channels.
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Keep a record of all notices sent out and follow up with recipients to ensure that the necessary actions have been taken.

Who needs urgent field safety notice?

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Manufacturers
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Healthcare professionals
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Regulatory authorities
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Urgent field safety notice is a communication issued to report on product safety issues that pose a risk to the users.
Manufacturers, distributors, and importers of medical devices are required to file urgent field safety notice.
Urgent field safety notices should be filled out with detailed information about the safety issue, affected products, and proposed corrective actions.
The purpose of urgent field safety notice is to inform regulators, healthcare providers, and patients about potential risks associated with a medical device.
Information such as the description of the safety issue, affected product codes or serial numbers, distribution details, and proposed corrective actions must be reported on urgent field safety notice.
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