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This document serves as a consolidated global recall notification addressing multiple issues with the Terumo® Advanced Perfusion System 1 and outlines corrective actions and updated maintenance procedures.
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How to fill out urgent field safety notice
How to fill out Urgent FIELD SAFETY NOTICE
01
Begin by locating the Urgent FIELD SAFETY NOTICE template.
02
Fill in the date at the top of the notice.
03
Provide a clear title that identifies the field safety notice.
04
Specify the affected products or devices.
05
Include a description of the safety issue and any potential risks.
06
Detail the actions required from the recipients, such as inspections or returns.
07
Outline the timeline for compliance and follow-up.
08
Include contact information for queries and further instructions.
09
Ensure the notice is printed on official letterhead if applicable.
10
Distribute the notice to all relevant stakeholders.
Who needs Urgent FIELD SAFETY NOTICE?
01
Healthcare providers who use the affected products.
02
Medical device distributors and retailers.
03
Patients who may be impacted by the safety issue.
04
Regulatory bodies that oversee product safety.
05
Internal teams within the manufacturer, such as quality assurance and safety personnel.
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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 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 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 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 a safety notice?
Safety notices are issued where, under certain circumstances, an unsafe situation could arise. For example, where instructions or labelling for use are not clear, additional guarding may be required, operating parameters or procedures need to be changed, where this could, in some cases, lead to an injury.
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 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 is a communication issued by a manufacturer or regulatory authority to inform healthcare professionals and users about potential safety issues with a medical device or product that may pose a risk to patients.
Who is required to file Urgent FIELD SAFETY NOTICE?
Manufacturers of medical devices or related products are required to file an Urgent FIELD SAFETY NOTICE when they identify a safety concern that could affect patient health or safety.
How to fill out Urgent FIELD SAFETY NOTICE?
To fill out an Urgent FIELD SAFETY NOTICE, manufacturers must provide specific details including the product description, nature of the safety issue, affected lot numbers, recommendations for recipients, and contact information for further assistance.
What is the purpose of Urgent FIELD SAFETY NOTICE?
The purpose of an Urgent FIELD SAFETY NOTICE is to ensure timely communication of safety information to healthcare professionals and users, enabling them to take necessary actions to mitigate potential risks associated with a medical device.
What information must be reported on Urgent FIELD SAFETY NOTICE?
The information that must be reported includes the product identification, nature of the safety issue, affected batches or lots, recommended actions for users, and contact information for the manufacturer or responsible entity.
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