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Benton, Dickinson and Company BD Biosciences 2350 Hume Drive San Jose, CA 95131 Bdbiosciences.com BD.current PRODUCT RECALL 22 March 2019 Product Name BD Horizon BV421 Mouse AntiAhRCatalog (Ref) No.
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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 device recall.
02
Notify the appropriate regulatory authority.
03
Prepare a recall strategy and action plan.
04
Notify affected customers and distributors.
05
Implement the recall process as per the action plan.
06
Monitor and track the recall progress.
07
Report the completion of the recall to the regulatory authority.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices.
02
Authorized representatives of class 2 medical devices.
03
Distributors of class 2 medical devices.
04
Healthcare facilities using class 2 medical devices.
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What is class 2 device recall?
Class 2 device recall is a recall initiated by a manufacturer or distributor for a device that 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 or distributors of medical devices are required to file a class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall forms can typically be filled out online through the FDA's MedWatch website or by submitting a paper form through mail or fax.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to address potentially harmful medical devices in a timely manner to prevent harm to patients.
What information must be reported on class 2 device recall?
Class 2 device recall reports must include information such as the reason for the recall, details about the affected devices, number of units affected, distribution information, and actions taken by the manufacturer.
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