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URGENT DEVICE
CORRECTION
March DD, 2017 (to be adapted locally)Dear Healthcare Provider: (to be adapted locally), Problem
DescriptionAffected
Product
(to be adapted
locally)Hazard Involved Baxter
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What is urgent device?
Urgent device is a type of report that must be filed to notify authorities of a device that poses a risk to public health or safety.
Who is required to file urgent device?
Manufacturers, importers, and distributors of medical devices are required to file urgent device reports.
How to fill out urgent device?
Urgent device reports can usually be filed online through the appropriate regulatory authority's website.
What is the purpose of urgent device?
The purpose of urgent device reports is to quickly alert authorities about devices that may pose a risk to public health or safety so that appropriate action can be taken.
What information must be reported on urgent device?
Urgent device reports must include information about the device, the identified risk, actions taken to address the risk, and contact information for the manufacturer or distributor.
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