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August 19, 2019, To:HospitalsSubject:URGENT MEDICAL DEVICE FIELD SAFETY NOTICE REMOVALReference:MFA 201900185Affected Product: Cal car Trimmer Shaft Item Number Lot Numbered Number110032331784060
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Class 2 device recall form should be filled out by gathering all necessary information regarding the device being recalled
02
Include details such as device name, model number, manufacture date, reason for recall, and potential hazards associated with the device
03
Submit the completed form to the appropriate regulatory authority for review and approval
Who needs class 2 device recall?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Regulatory authorities overseeing medical device safety
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What is class 2 device recall?
Class 2 device recall is initiated when a product has a potential for causing temporary or medically reversible health problems.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers of medical devices are 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 responsible party must provide all necessary information regarding the issue 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 devices that violate the Federal Food, Drug, and Cosmetic Act.
What information must be reported on class 2 device recall?
Information such as the reason for the recall, the affected product details, and the actions to address the issue must be reported on a class 2 device recall.
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