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Get the free Class 2 Device Recall BD - Accessdata.fda.gov

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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

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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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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.
Manufacturers, distributors, importers, and device user facilities are required to file 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.
The purpose of class 2 device recall is to remove or correct a device that is violating FDA laws or regulations.
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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