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Benton, Dickinson and Company BD Biosciences 2350 Hume Drive San Jose, CA 95131 Bdbiosciences.com BD.current MEDICAL DEVICE RECALL BD FACSLyricTM Flow Cyclometer 19 August 2019 For the Attention of:
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Gather all relevant information about the device being recalled.
02
Fill out the FDA form for Class 2 device recall with accurate details.
03
Clearly state the reason for the recall and potential risks associated with the device.
04
Provide contact information for the person responsible for coordinating the recall.
05
Submit the completed form to the FDA for review and approval.
Who needs class 2 device recall?
01
Manufacturers and distributors of medical devices that have been determined to have a defect or pose a potential health risk to consumers.
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What is class 2 device recall?
Class 2 device recall involves removing or correcting a device that may cause temporary or reversible health problems.
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 recalls can be filled out by submitting a recall strategy to the appropriate regulatory agency.
What is the purpose of class 2 device recall?
The purpose of a class 2 device recall is to protect the public health by removing or correcting devices that may pose a risk.
What information must be reported on class 2 device recall?
Class 2 device recall reports must include details about the device, the reason for the recall, and the actions being taken.
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