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Telefax Medical IDA Business & Technology Park Dublin Road, Alone Vestments, Ireland February2024URGENT FIELD SAFETY NOTICE Type of Action:Recall Removal Arrow Newsflash Radial Artery Catheterization
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How to fill out class 1 device recall
How to fill out class 1 device recall
01
Identify the reason for the recall
02
Notify relevant stakeholders (e.g. customers, regulatory authorities)
03
Provide instructions for returning or disposing of the devices
04
Conduct an investigation to determine the scope and impact of the recall
05
Implement corrective actions to prevent similar issues in the future
Who needs class 1 device recall?
01
Manufacturers of class 1 medical devices
02
Distributors of class 1 medical devices
03
Healthcare facilities using class 1 medical devices
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What is class 1 device recall?
A Class 1 device recall is issued when there is a reasonable chance that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Who is required to file class 1 device recall?
Manufacturers, importers, and distributors of medical devices are required to file a Class 1 device recall with the FDA.
How to fill out class 1 device recall?
To fill out a Class 1 device recall, you must complete the FDA's Form 3617, providing details such as product information, reason for the recall, and actions taken to inform customers.
What is the purpose of class 1 device recall?
The purpose of a Class 1 device recall is to protect public health by removing dangerous or defective medical devices from the market to prevent harm to patients.
What information must be reported on class 1 device recall?
Information that must be reported includes the device name, model number, description of the defect, reasons for the recall, and the number of units affected.
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