Get the free URGENT Field Safety Notice: RA1690954

XX December 2017URGENT Field Safety Notice: RA1690954FSCA Identifier:Type of Action: Product description: Item No.:Product Field Action RA1690954RECALLREMOVALGuider Softie OF Guide Catheters attached listener customer:Stryker Neurovascular, as the distributor of the Guider Guide Catheter product, is initiating biomedical Device Recall in coordination with Boston Scientific, the manufacturer of this device.

How to fill out urgent field safety notice

How to fill out urgent field safety notice

1. To fill out an urgent field safety notice, follow these steps:
2. Start by gathering all the necessary information regarding the safety issue or concern that prompted the notice.
3. Clearly define the nature of the safety issue and provide a concise description.
4. Include details about the affected products, such as model numbers, serial numbers, and any specific batch information.
5. Prepare a comprehensive explanation of the potential risks or hazards associated with the safety issue.
6. Provide clear instructions for users or customers on how to identify whether they possess the affected products.
7. Specify the recommended actions to be taken by individuals or organizations upon receiving the notice.
8. Include contact information or a designated point of contact for any inquiries or additional information.
9. Ensure the urgency of the notice is evident and emphasize the importance of prompt attention and compliance.
10. Review the completed field safety notice for accuracy and clarity before dissemination.
11. Distribute the notice through the appropriate channels or platforms, such as email, physical mail, website postings, or industry-specific databases.

Who needs urgent field safety notice?

1. Urgent field safety notices are necessary for any individuals, organizations, or entities involved in the production, distribution, or usage of products that pose potential safety risks.
2. This includes manufacturers, suppliers, retailers, service providers, regulatory bodies, and end-users.
3. Anyone who may have acquired or come into contact with the affected products needs to be informed promptly to ensure their safety and prevent any potential harm.
4. Therefore, it is crucial that urgent field safety notices are recognized and responded to by all relevant stakeholders.

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What is urgent field safety notice?

Urgent field safety notice is a communication issued to inform users and health care providers about potential risks associated with a medical device.

Who is required to file urgent field safety notice?

Manufacturers, sponsors, and other entities responsible for the medical device are required to file urgent field safety notices.

How to fill out urgent field safety notice?

Urgent field safety notices are typically filled out by providing detailed information about the potential risk, affected devices, recommended actions, and contact information for further inquiries.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notice is to ensure the safety of patients and users by providing timely information about potential risks associated with a medical device.

What information must be reported on urgent field safety notice?

Details about the potential risk, affected devices, recommended actions, contact information, and any other relevant information must be reported on urgent field safety notices.