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This document is an urgent notice from Cetro Medical AB regarding corrective actions needed for certain CETRO products due to a material change by the supplier. It outlines the affected products,

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How to fill out urgent field safety notice

01

Begin by identifying the product and its details including model and serial numbers.

02

Clearly state the reason for the urgent field safety notice.

03

Provide instructions for the recipients on what actions to take.

04

Include information on how to contact your organization for further assistance.

05

Specify a deadline for reporting compliance or issues.

Who needs urgent field safety notice?

01

Healthcare providers using the affected product.

02

Patients or end-users of the product.

03

Regulatory bodies overseeing product safety.

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What is urgent field safety notice?

An urgent field safety notice is a communication issued to inform healthcare professionals and users about a safety concern regarding a medical device or health product that may pose risks to patient safety.

Who is required to file urgent field safety notice?

Manufacturers of medical devices and health products are required to file an urgent field safety notice when they become aware of a safety issue that may affect the performance or safety of their products.

How to fill out urgent field safety notice?

To fill out an urgent field safety notice, providers should include information about the device/product involved, a description of the safety issue, the potential risks, recommended actions for users, and contact information for follow-up.

What is the purpose of urgent field safety notice?

The purpose of an urgent field safety notice is to communicate critical safety information quickly to prevent adverse events and protect patients and users from potential harm.

What information must be reported on urgent field safety notice?

The information that must be reported on an urgent field safety notice includes the identification of the product, description of the issue, the potential risks involved, corrective actions to take, and channels for reporting further issues.

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