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BD Medication Delivery Solutions 1 Benton Drive Franklin Lakes, NJ 07417 USA BD.current MEDICAL DEVICE RECALL Date: 14 September 2020 Product NameCatalog (Ref) No. Lot No. BD Neva Closed IV Catheter
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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 appropriate regulatory authorities
03
Prepare a communication plan for affected customers
04
Provide instructions on how to return the device
05
Keep detailed records of the recall process
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices
02
Distributors of class 2 medical devices
03
Healthcare facilities that use 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 subject to removal or correction by the manufacturer due to potential health risks.
Who is required to file class 2 device recall?
Manufacturers, distributors, or importers of medical devices are required to file class 2 device recalls.
How to fill out class 2 device recall?
Class 2 device recall can be filled out by submitting a recall initiation report to the regulatory authority with relevant information about the device and the reason for recall.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to ensure the safety and effectiveness of medical devices and protect public health.
What information must be reported on class 2 device recall?
Information such as the device description, reason for recall, number of affected devices, distribution dates, and potential health risks must be reported on class 2 device recall.
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