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Greenfield Safety NoticeUrgent Field Safety Notice
DEVICE: LAB Transjugular Liver Biopsy System
FSA: 202012101
RECALL Return to Argon Medical Devices, Inc.
Date: December 10, 2020,
Re:RECALL LAB Transjugular
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Identify the reason for the recall
02
Gather necessary information about the affected devices
03
Notify the appropriate regulatory authorities
04
Develop a communication plan for affected customers
05
Implement the recall process according to regulatory guidelines
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices who have identified a safety issue or defect with their products that could pose a risk to patients or users
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What is class 2 device recall?
Class 2 device recall is a situation where a medical device is removed from the market due to a potential health risk.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers of medical devices are required to file class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall can be filled out by submitting a recall submission to the relevant regulatory authority.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to protect public health and safety by removing potentially harmful medical devices from the market.
What information must be reported on class 2 device recall?
Class 2 device recall must include information such as the reason for the recall, the affected product details, and the corrective action being taken.
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