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BD Urology and Critical Care 8195 Industrial Blvd Covington, GA 30014 www.bd.comMEDICAL DEVICE CORRECTION March 23, 2020, Product NameCatalog #Serial #satiate of ManufactureSensica UO System for ICUSCCS1001See

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How to fill out medical device recall notification

01

Gather all necessary information about the medical device being recalled, including product name, model number, lot number, and reason for recall.

02

Prepare a detailed notification letter explaining the reason for the recall and the potential risks associated with the device.

03

Identify all affected parties, including healthcare providers, distributors, and patients who may have the device.

04

Send out the recall notification letter to all affected parties, either by mail, email, or through an online portal.

05

Monitor and track responses from the recipients of the recall notification to ensure they have taken appropriate action.

Who needs medical device recall notification?

01

Manufacturers of medical devices who have identified a safety issue with their product.

02

Healthcare providers who have distributed or used the recalled medical device.

03

Patients who have been implanted with or are using the recalled medical device.

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What is medical device recall notification?

Medical device recall notification is a process used by the FDA to alert the public and medical community about potential safety issues with a specific medical device.

Who is required to file medical device recall notification?

Manufacturers, distributors, and importers of medical devices are required to file medical device recall notifications.

How to fill out medical device recall notification?

To fill out a medical device recall notification, the responsible party must provide detailed information about the device, the reason for the recall, the potential risks involved, and the steps being taken to address the issue.

What is the purpose of medical device recall notification?

The purpose of medical device recall notification is to protect the public health by ensuring that unsafe devices are removed from the market or corrected.

What information must be reported on medical device recall notification?

Medical device recall notifications must include information such as the device name, model number, lot number, reason for recall, risk assessment, and corrective action being taken.

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