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This document serves as a notice for the voluntary recall of certain models of Medfusion® Syringe Infusion Pumps due to alarm message events, outlining actions for users and affected serial numbers

How to fill out urgent field safety notice

How to fill out Urgent Field Safety Notice

1. Begin by gathering all necessary information related to the medical device or product.
2. Clearly state the purpose of the Urgent Field Safety Notice at the top.
3. Provide a detailed description of the safety issue, including possible risks and consequences.
4. Outline the actions that need to be taken by users or healthcare providers.
5. Include any deadlines for response or actions to be taken.
6. Provide contact information for further questions or clarification.
7. Ensure that the notice is clear, concise, and free of technical jargon.

Who needs Urgent Field Safety Notice?

1. Healthcare professionals who use the medical device.
2. Patients who may be affected by the safety issue.
3. Distributors and suppliers of the device.
4. Regulatory bodies overseeing medical devices.

People Also Ask about

What is a field safety notice?

Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.

What is an example of a field safety corrective action?

The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has

What is field safety?

Development of field safety plans is critical for identifying and mitigating risk in the field. These plans allow you to prepare for situations you may encounter and know how to respond. The purpose of the plan is to make sure all staff and students are not caught unprepared and are aware of hazards they may encounter.

What is a FSCA in medical devices?

A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.

What is a field safety notification?

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.

For pdfFiller’s FAQs

What is Urgent Field Safety Notice?

An Urgent Field Safety Notice is a communication issued by a manufacturer or supplier to inform users and stakeholders about potential risks associated with a medical device or product and necessary actions to mitigate those risks.

Who is required to file Urgent Field Safety Notice?

Manufacturers, distributors, and suppliers of medical devices are required to file an Urgent Field Safety Notice when they identify potential risks that could affect the safety or performance of their devices.

How to fill out Urgent Field Safety Notice?

To fill out an Urgent Field Safety Notice, include the device details, the nature of the risk, recommended actions for users, and the timeline for addressing the risks, along with contact information for further queries.

What is the purpose of Urgent Field Safety Notice?

The purpose of an Urgent Field Safety Notice is to ensure that users are aware of any safety issues that might pose a risk to patients or healthcare providers and to guide them on the necessary actions to take.

What information must be reported on Urgent Field Safety Notice?

The Urgent Field Safety Notice must report the product name, batch or serial numbers, description of the problem, potential risks, corrective actions to be taken, and contact information for the manufacturer.