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10020 Pacific Mesa Blvd San Diego, CA 92121 18888764287 (toll-free)www.bd.comMedical Device Product Notification AFFECTED DEVICE: Alarms Etc Oz Module (Model 8300) July 3, 2019, Dear Valued Alarms
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How to fill out medical device recall notification
How to fill out medical device recall notification
01
Obtain the appropriate recall notification form from the regulatory authority or medical device manufacturer.
02
Fill out all required fields on the form including details of the device, reason for recall, and contact information.
03
Provide a description of the potential health hazards associated with the device and any reported incidents.
04
Submit the completed form to the regulatory authority or medical device manufacturer within the specified timeframe.
Who needs medical device recall notification?
01
Medical device manufacturers who have identified a defect or potential safety risk with their device
02
Healthcare providers who have distributed or used the device in patient care
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What is medical device recall notification?
Medical device recall notification is a process where manufacturers and other parties involved inform the relevant authorities and customers about a defective medical device that may pose a risk to public health.
Who is required to file medical device recall notification?
Manufacturers, distributors, and importers of medical devices are required to file medical device recall notification.
How to fill out medical device recall notification?
Medical device recall notification can be filled out electronically or in paper form, following the specific requirements of the regulatory authority.
What is the purpose of medical device recall notification?
The purpose of medical device recall notification is to ensure the safety of patients and users by removing or correcting defective medical devices from the market.
What information must be reported on medical device recall notification?
Information that must be reported on medical device recall notification includes the identification of the device, the reason for the recall, the potential health risks, and the actions to be taken.
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