Get the free Class 2 Device Recall StarClose SE Vascular Closure System
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Modify country specific contact informationURGENT FIELD SAFETY NOTICE/ DEVICE RECALLCOMMERCIAL NAME: Staircase SE Vascular Closure System
FS Identifier: February 10, 2017,
Type of Action:
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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 of the class 2 device.
02
Notify the appropriate regulatory bodies about the recall.
03
Contact customers who have purchased the device and provide instructions on how to return it.
04
Keep detailed records of all communications and actions taken during the recall process.
05
Implement corrective actions to prevent similar issues in the future.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices who have identified a need to recall their product due to safety concerns or defects.
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What is class 2 device recall?
Class 2 device recall is initiated when a medical device has a moderate risk of causing harm to the patient.
Who is required to file class 2 device recall?
The manufacturer or distributor of the medical device is required to file a class 2 device recall.
How to fill out class 2 device recall?
To fill out a class 2 device recall, the manufacturer or distributor must provide details about the device, reason for recall, and actions to be taken.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct medical devices that may pose a risk to patients.
What information must be reported on class 2 device recall?
The information reported on class 2 device recall includes device identification, reason for recall, risk assessment, and proposed corrective actions.
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