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This document serves as a notice regarding the recall of specific lots of the Terumo TenderFlow Pediatric Arterial Cannula due to a dimensional fit issue with the introducer, and provides instructions
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice
01
Begin with the date of the notice.
02
Clearly state the product involved and its identification details.
03
Describe the nature of the safety issue and its potential impact.
04
Provide instructions on how to handle the affected product.
05
Include information on the actions to be taken by the recipients.
06
Outline the timelines for reporting back any relevant information.
07
Offer contact information for further inquiries.
Who needs Urgent Field Safety Notice?
01
Healthcare providers who use the affected product.
02
Distributors responsible for the product delivery.
03
Regulatory bodies monitoring product safety.
04
Patients who may be impacted by the safety issue.
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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.
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What is Urgent Field Safety Notice?
An Urgent Field Safety Notice (UFSN) is a communication issued by a manufacturer to alert users and stakeholders about potential safety issues related to a medical device or product that may pose a risk to patients, users, or others.
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 to inform users and relevant regulatory authorities about identified safety concerns.
How to fill out Urgent Field Safety Notice?
To fill out an Urgent Field Safety Notice, the manufacturer should provide information such as the product details, description of the safety issue, potential risks, recommended 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 ensure that users and stakeholders are informed of potential safety risks in order to take appropriate actions to mitigate harm and ensure patient safety.
What information must be reported on Urgent Field Safety Notice?
The information that must be reported on an Urgent Field Safety Notice includes the product identification details, nature of the safety issue, risk assessment, recommended actions, instructions for users, and contact details for follow-up.
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