Get the free Class 2 Device Recall BD Affirm VPIII ... - Accessdata.fda.gov
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BD Diagnostic Systems 7 Love ton Circle Sparks, MD 21152 tell: 4103164000 fax: 4103164066 www.bd.comURGENT PRODUCT RECALLAUGUST 2015 Cat. NumberUnitBD Affirm VIII Microbial Identification Tests446257120
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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
02
Notify the appropriate regulatory authorities
03
Notify affected customers
04
Develop a plan for fixing or replacing the devices
05
Keep detailed records of the recall process
Who needs class 2 device recall?
01
Manufacturers and distributors of class 2 medical devices
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What is class 2 device recall?
Class 2 device recall is a situation where a medical device is judged to have a reasonable probability that it may cause serious adverse health consequences or death.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers of medical devices are required to file for a class 2 device recall.
How to fill out class 2 device recall?
To fill out a class 2 device recall, the appropriate documentation must be submitted to the relevant regulatory authorities, including details of the device, reason for recall, and proposed actions.
What is the purpose of class 2 device recall?
The purpose of a class 2 device recall is to remove or correct a medical device that is deemed to pose a potential risk to public health.
What information must be reported on class 2 device recall?
Information that must be reported on a class 2 device recall includes details of the device, reason for recall, number of affected devices, and proposed corrective actions.
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