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This document provides a safety notice regarding the recall of the Edwards Lifesciences 'Endoclamp Aortic Catheter' Model No. EC1001 due to reports of balloon ruptures during use, emphasizing the

How to fill out urgent field safety notice

How to fill out URGENT FIELD SAFETY NOTICE

1. Start with the title 'URGENT FIELD SAFETY NOTICE'.
2. Include the date of issuance.
3. Provide a brief description of the product and the specific issue.
4. Clearly state the affected lot numbers or serial numbers.
5. Describe the potential risks associated with the issue.
6. Outline the actions required by recipients (e.g., discontinuing use, returning products).
7. Include contact information for further questions or concerns.
8. Conclude with a reminder to share the notice with affected parties.

Who needs URGENT FIELD SAFETY NOTICE?

1. Healthcare professionals who use the product.
2. Distributors and suppliers of the product.
3. Affected patients or customers.
4. Regulatory bodies overseeing the product's safety.

People Also Ask about

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 the functional safety standard for medical devices?

Generally, functional safety deals with hazards, which arise from the function of a device. ing to IEC 61508 it is the ability of a safety-related system to carry out the actions necessary to achieve a safe state for the EUC (equipment under control) or to maintain a safe state for the EUC.

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 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 a benefit risk assessment for medical devices?

It entails evaluating the device's possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being used by patients without harm.

What is the full form of FSCA?

The Financial Sector Conduct Authority (FSCA) is responsible for market conduct regulation and supervision.

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 regulatory authority to inform users about potential safety issues with a medical device or product that could pose a risk to patient safety.

Who is required to file URGENT FIELD SAFETY NOTICE?

Manufacturers, importers, and healthcare organizations that identify a safety concern related to a medical device are required to file an URGENT FIELD SAFETY NOTICE.

How to fill out URGENT FIELD SAFETY NOTICE?

To fill out an URGENT FIELD SAFETY NOTICE, provide accurate details of the safety issue, its potential impact, necessary corrective actions, product identification, and affected user information, ensuring compliance with regulatory standards.

What is the purpose of URGENT FIELD SAFETY NOTICE?

The purpose of an URGENT FIELD SAFETY NOTICE is to promptly alert users about safety hazards, recommend actions to mitigate risk, and ensure patient safety and effective use of medical devices.

What information must be reported on URGENT FIELD SAFETY NOTICE?

The information that must be reported includes a description of the safety issue, identification of affected products, instructions for use, potential risks, contact information for further guidance, and any required actions for users.