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Get the free Class 2 Device Recall MEDRAD Intego PET Infusion System - Food and Drug ...

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URGENT FIELD SAFETY NOTICE Commercial name of the affected product: Med rad Continuum MR Infusion System FSC AID: SA13RAD13 Type of action: Inspection of the system bracket/pin on nonwireless systems
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How to fill out class 2 device recall

01
Identify the reason for the recall of the class 2 device.
02
Notify all affected parties including customers, regulators, and distributors.
03
Prepare a recall strategy and communicate it clearly to all stakeholders.
04
Provide instructions on how to return or dispose of the recalled devices.
05
Keep detailed records of the recall process for documentation and audit purposes.

Who needs class 2 device recall?

01
Manufacturers
02
Distributors
03
Regulatory authorities
04
Healthcare facilities
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Class 2 device recall is a voluntary action taken by a manufacturer to remove or correct a device that violates FDA regulations and poses a moderate risk to health.
Manufacturers of medical devices are required to file class 2 device recalls.
To fill out a class 2 device recall, manufacturers must gather information on the affected devices, reason for recall, actions taken, and contact details.
The purpose of a class 2 device recall is to remove or correct a medical device that poses a moderate risk to health.
Class 2 device recall must include information on the affected devices, reason for recall, actions taken, and contact details for consumers.
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