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This document notifies customers of a recall of Pinnacle Cure Sleeves due to a labeling error which may affect patient safety. Customers are requested to return the affected products.
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How to fill out urgent field safety notice
How to fill out Urgent Field Safety Notice
01
Begin by reviewing the Urgent Field Safety Notice document provided.
02
Fill in the date at the top of the notice.
03
Provide details about the product affected, including model number and serial number.
04
Clearly describe the safety issue or risk associated with the product.
05
Include specific instructions for users on what actions to take.
06
Provide contact information for further inquiries or assistance.
07
Ensure that the notice is signed and dated by an authorized representative.
Who needs Urgent Field Safety Notice?
01
Healthcare providers using the affected products.
02
Regulatory bodies monitoring product safety.
03
Distributors and suppliers of the product.
04
Patients who may be affected by the potential risks.
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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 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 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 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.
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.
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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 users about a safety issue with a medical device or product that may pose a risk to health.
Who is required to file Urgent Field Safety Notice?
Manufacturers and authorized representatives of medical devices are required to file an Urgent Field Safety Notice when there is a safety concern that could impact the safety or effectiveness of their products.
How to fill out Urgent Field Safety Notice?
To fill out an Urgent Field Safety Notice, include details such as the product description, nature of the safety issue, affected batches, 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 promptly inform users and healthcare professionals about potential risks associated with a product, enabling them to take necessary precautions to ensure safety.
What information must be reported on Urgent Field Safety Notice?
The information required includes product identification, description of the problem, risk assessment, actions that should be taken by users, and contact details for further inquiries.
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