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005763810/08/2022DGDMFMDSA Allegato Tenth 1 (A01)URGENT: MEDICAL DEVICE VOLUNTARY Recall Number: RA20223037482Guider Softie OF Guide Catheter Attn: Risk Management/ Recall Coordinator/ Inventory Manager

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How to fill out medical device voluntary recall

01

Identify the reason for the recall

02

Determine the affected devices and lot numbers

03

Notify relevant regulatory authorities

04

Develop a recall strategy including communication plan

05

Prepare and distribute recall notices to customers

06

Monitor and track the progress of the recall

07

Evaluate the effectiveness of the recall

Who needs medical device voluntary recall?

01

Manufacturers of medical devices

02

Distributors of medical devices

03

Healthcare facilities that use medical devices

04

Patients who have been impacted by a faulty medical device

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What is medical device voluntary recall?

A medical device voluntary recall is a proactive measure taken by a manufacturer to remove a product from the market due to safety or compliance issues that could pose a risk to patients or users.

Who is required to file medical device voluntary recall?

Manufacturers, importers, and distributors of medical devices are required to file a voluntary recall if they identify that their product may be unsafe or violates regulatory standards.

How to fill out medical device voluntary recall?

To fill out a medical device voluntary recall, manufacturers must complete a recall submission form detailing the product description, the reason for the recall, the affected lot numbers, and any actions that have been taken or will be taken to address the recall.

What is the purpose of medical device voluntary recall?

The purpose of a medical device voluntary recall is to protect public health by removing potentially harmful products from the market, ensuring that patients and users are not exposed to unsafe devices.

What information must be reported on medical device voluntary recall?

Information that must be reported includes the product name, model and serial numbers, a description of the issue, the date of the recall, and a description of any corrective actions taken.

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