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This document serves as an Urgent Field Safety Notice regarding the DBB-06 and DBB-07 Hemodialysis Devices, highlighting a patient leakage current issue when used with central venous catheters and
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What is urgent field safety notice?
Urgent field safety notice is a notification issued by regulatory authorities to inform healthcare professionals and the general public about a potential safety issue associated with a medical device.
Who is required to file urgent field safety notice?
Manufacturers, importers, and distributors of medical devices are generally required to file urgent field safety notices.
How to fill out urgent field safety notice?
Filling out an urgent field safety notice typically involves providing detailed information about the product, the safety issue, recommended actions, and contact information for further inquiries.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to ensure that healthcare professionals and users of medical devices are promptly informed about potential safety concerns and take appropriate actions to mitigate risks.
What information must be reported on urgent field safety notice?
An urgent field safety notice usually requires information such as the identification of the medical device, description of the safety issue, potential risks, recommended actions, and contact information for reporting adverse events.
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