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This document is a field safety notice regarding the recall of specific Teleflex Medical catheters due to issues related to devices getting stuck in their sheath, which can delay critical therapy
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How to fill out field safety notice
How to fill out FIELD SAFETY NOTICE
01
Open the FIELD SAFETY NOTICE template.
02
Fill in the date of issuance at the top of the document.
03
Clearly state the title of the notice.
04
Identify the product(s) affected by the safety issue.
05
Provide a detailed description of the safety concern.
06
Specify the actions required from the recipients.
07
Include contact information for further inquiries.
08
Review the notice for clarity and accuracy before distribution.
Who needs FIELD SAFETY NOTICE?
01
Healthcare professionals who use the affected product.
02
Distributors and suppliers of the product.
03
Regulatory bodies overseeing product safety.
04
Patients affected by the safety issue.
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People Also Ask about
What is the meaning of 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.
What is a FSCA in MDR?
A Field Safety Corrective Action (FSCA) is defined in Article 2(68) of Regulation (EU) 2017/745 on medical devices (MDR) and Article 2(71) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the
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 are field safety notices?
A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.
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What is FIELD SAFETY NOTICE?
A FIELD SAFETY NOTICE is a communication issued by manufacturers to inform users about potential safety issues related to a medical device, including corrective actions that should be taken to mitigate risks.
Who is required to file FIELD SAFETY NOTICE?
Manufacturers of medical devices are required to file a FIELD SAFETY NOTICE when they identify a safety issue that could affect the performance or safety of their device.
How to fill out FIELD SAFETY NOTICE?
To fill out a FIELD SAFETY NOTICE, manufacturers must provide clear and concise information about the safety issue, the affected product, corrective actions, and any necessary instructions for users. Specific templates or guidelines may be provided by regulatory authorities.
What is the purpose of FIELD SAFETY NOTICE?
The purpose of a FIELD SAFETY NOTICE is to ensure the safety of patients and users by providing timely information about potential risks associated with a medical device and guiding corrective measures.
What information must be reported on FIELD SAFETY NOTICE?
A FIELD SAFETY NOTICE must report information such as the product details, description of the safety issue, potential risks, recommended actions for users, and contact information for further inquiries.
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