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This document is an urgent notice addressing the proper placement of bottles in the CellSearch® Circulating Tumor Cell Kit to avoid erroneous patient results due to incorrectly placed or duplicate

How to fill out urgent field safety notice

How to fill out Urgent Field Safety Notice

1. Identify the product and issue being reported in the Urgent Field Safety Notice.
2. Include the unique identification number of the notice.
3. Provide a description of the risk associated with the product.
4. Specify the actions users should take to mitigate the risk.
5. Include contact information for further inquiries or support.
6. Ensure to distribute the notice to all relevant stakeholders and keep records of the distribution.

Who needs Urgent Field Safety Notice?

1. Healthcare professionals who use the affected product.
2. Medical institutions and facilities managing patient care.
3. Distributors and suppliers of the product.
4. Regulatory authorities responsible for product safety.

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 (UFSN) is an official communication issued by medical device manufacturers to inform customers about a potential or actual safety issue related to a medical device that may pose a risk to patient or user safety.

Who is required to file Urgent Field Safety Notice?

Medical device manufacturers are required to file an Urgent Field Safety Notice when they identify a safety issue with their product that could affect patients or users.

How to fill out Urgent Field Safety Notice?

To fill out an Urgent Field Safety Notice, manufacturers need to complete a standardized form that includes details about the device, the nature of the safety issue, recommended actions, and information on how to report any adverse events.

What is the purpose of Urgent Field Safety Notice?

The purpose of an Urgent Field Safety Notice is to promptly inform affected users and healthcare providers about safety concerns, ensuring that appropriate actions can be taken to mitigate risks associated with the device.

What information must be reported on Urgent Field Safety Notice?

The Urgent Field Safety Notice must include identification of the device, description of the issue, recommended actions for users, risk evaluation, contact information for further inquiries, and instructions for reporting adverse events.