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This document details the urgent recall of Dk-line and Okta-line perfluorocarbon liquids due to sterility concerns, outlining necessary actions for health care professionals.
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by a manufacturer or regulatory authority to inform stakeholders about a potential safety risk associated with a medical device or product, requiring immediate action.
Who is required to file urgent field safety notice?
The manufacturer or authorized representative of the medical device or product is required to file an urgent field safety notice.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, include relevant details about the product, nature of the risk, affected batches, required actions for users, and contact information for further inquiries.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to promptly alert users and stakeholders about risks associated with a product to ensure their safety and to outline necessary actions to mitigate those risks.
What information must be reported on urgent field safety notice?
Information that must be reported on an urgent field safety notice includes product identification, description of the safety issue, affected lot numbers, recommended actions, and contact information of the manufacturer.
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