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Benton, Dickinson and Company
1 Benton Drive
Franklin Lakes, NJ 07417
BD.com July 17, 2019Product name /
Catalog number
See AppendixURGENT MEDICAL DEVICE PRODUCT ADVISORY
BD MAX Reagents
Lot numbers
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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 and gather all relevant information.
02
Notify the appropriate regulatory body about the recall.
03
Identify the affected devices and document their serial numbers.
04
Notify customers about the recall and provide instructions on returning the devices.
05
Replace or repair the devices as needed.
Who needs class 2 device recall?
01
Manufacturers of medical devices that have been determined to pose a moderate risk to the health and safety of patients may need to issue a class 2 device recall.
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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 a remote risk of serious health problems.
Who is required to file class 2 device recall?
Manufacturers, distributors, importers, and device user facilities are required to file class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall must be filled out with detailed information about the reason for the recall, affected lot numbers, potential risks, and actions to be taken by customers.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct a device that is violating FDA laws or regulations.
What information must be reported on class 2 device recall?
Class 2 device recall must include information such as product name, model number, lot number, reason for recall, risk assessment, and actions to be taken.
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