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1450 Brooks Road Memphis, TN 38116 USA19013962121 18008215700 www.smithnehew.comUrgent Medical Device Recall Notice WR201909 May 13, 2019Insert Address Dear Customer, cc: Chairman Medical Board and
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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
Collect all necessary information related to the device including model number, serial number, manufacturing date, and batch number
03
Notify the appropriate regulatory authorities about the recall
04
Develop a plan for notifying customers and users of the device about the recall
05
Provide instructions on how to return or dispose of the recalled devices
06
Monitor and document the progress of the recall process
Who needs class 2 device recall?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Healthcare facilities and providers who use the devices
04
Patients who have been prescribed or are using the devices
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What is class 2 device recall?
Class 2 device recall is a situation where a medical device may cause temporary or reversible health problems, or where the probability of serious health problems is remote.
Who is required to file class 2 device recall?
Manufacturers and distributors of medical devices are required to file class 2 device recalls.
How to fill out class 2 device recall?
Class 2 device recall should be filled out by submitting a recall report to the appropriate regulatory body.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to inform the public and healthcare providers about potential risks associated with a medical device.
What information must be reported on class 2 device recall?
Class 2 device recall must include information on the reason for the recall, the product description, the lot number, and the actions to be taken by the healthcare providers.
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