Get the free URGENT FIELD SAFETY NOTICE SPA II Catalog No. 337170 - mhra gov
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This document serves as a notice to customers about inadequate sample dispensing associated with certain batches of the BD FACS™ Sample Preparation Assistant II and the steps to take if affected.
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What is urgent field safety notice?
Urgent Field Safety Notice (UFSN) is a communication issued by manufacturers, distributors, or authorized representatives in the medical device industry to address urgent safety concerns regarding a specific product.
Who is required to file urgent field safety notice?
Manufacturers, distributors, or authorized representatives in the medical device industry are required to file urgent field safety notices.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, the relevant information regarding the safety concern, applicable product details, and any necessary corrective actions should be provided accurately and completely according to the specified guidelines or template.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to promptly communicate and address urgent safety concerns related to a specific medical device, in order to mitigate risks and ensure patient safety.
What information must be reported on urgent field safety notice?
The urgent field safety notice should include information such as the description of the safety concern, affected product details (e.g., name, model, serial number), potential risks, recommended actions for healthcare professionals, and contact details for further assistance or inquiries.
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