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Perfusion, a wholly owned subsidiary of Benton, Dickinson and Company (BD) 10020 Pacific Mesa Blvd San Diego, CA 92121www.BD.current: Medical Device Recall BD Alarms PC Unit Model 8015 PC Unit Front
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How to fill out class 1 device recall
How to fill out class 1 device recall
01
Identify the reason for the recall
02
Notify appropriate regulatory authorities
03
Contact affected customers and distributors
04
Provide instructions for returning or disposing of the recalled devices
05
Implement corrections or changes to prevent future issues
Who needs class 1 device recall?
01
Manufacturers of class 1 medical devices
02
Distributors of class 1 medical devices
03
Healthcare facilities using class 1 medical devices
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What is class 1 device recall?
Class 1 device recall is the most serious type of recall for medical devices. It is issued when there is a reasonable probability that the use of or exposure to a faulty device will cause serious adverse health consequences or death.
Who is required to file class 1 device recall?
Manufacturers, distributors, and importers of medical devices are required to file class 1 device recalls.
How to fill out class 1 device recall?
To fill out a class 1 device recall, the responsible party must provide detailed information about the faulty device, the reason for the recall, and the potential health consequences.
What is the purpose of class 1 device recall?
The purpose of a class 1 device recall is to ensure that faulty medical devices posing serious health risks are removed from the market and no longer used by patients.
What information must be reported on class 1 device recall?
Class 1 device recall must include information about the device identification, reason for recall, health risks, distribution details, and actions to be taken by the recipients.
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