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Perfusion 75 North Fairway Drive Vernon Hills, IL 60061 www.bd.comURGENT MEDICAL DEVICE RECALL February 17, 2021, Product DescriptionCatalog Number DI Numbers. Mueller TM McCulloch Rigid Retractor
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Gather all necessary information about the device being recalled.
02
Notify the appropriate regulatory authorities about the recall.
03
Develop a communication plan to notify customers about the recall.
04
Prepare and distribute recall letters or notifications to affected customers.
05
Provide instructions on how to return or dispose of the recalled device.
06
Follow up with customers to ensure compliance with the recall.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices.
02
Distributors or retailers of class 2 medical devices.
03
Healthcare facilities or providers who have purchased or used class 2 medical devices.
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What is class 2 device recall?
Class 2 device recall is initiated when a medical device has a moderate risk of causing harm or potential danger to the patient.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers 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 appropriate regulatory agency's portal.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to ensure the safety of patients and to remove or correct devices that may pose a risk.
What information must be reported on class 2 device recall?
Information such as the reason for recall, affected product details, distribution information, and corrective action must be reported on a class 2 device recall.
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