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April 5, 2019Dear Healthcare Professional,
cc: Chairman Medical Board and relevant Head of Departments
Subject:URGENT MEDICAL DEVICE REMOVAL AND NOTICE OF DISCONTINUATIONAffected Product: T7 Cannulated
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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
Notify the appropriate regulatory authorities
03
Inform affected customers, suppliers, and distributors
04
Develop a recall strategy and timeline
05
Retrieve affected devices from the market
06
Evaluate the effectiveness of the recall
Who needs class 2 device recall?
01
Companies that have manufactured or distributed class 2 medical devices
02
Regulatory authorities overseeing medical device safety
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What is class 2 device recall?
Class 2 device recall is when a medical device is found to have a moderate risk of causing harm to the patient.
Who is required to file class 2 device recall?
Manufacturers, distributors, or importers of medical devices are required to file class 2 device recalls.
How to fill out class 2 device recall?
Class 2 device recalls should be filled out on the appropriate forms provided by the regulatory agency overseeing medical devices.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to notify the public and healthcare providers about the potential risks associated with the medical device.
What information must be reported on class 2 device recall?
Class 2 device recall must include information about the specific device, reason for recall, potential risks, and corrective actions.
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