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URGENT ? FIELD SAFETY NOTICE Edwards Life sciences Ascendra2 Transapical Delivery System Model numbers 9350AS23 & 9350AS26 Lot numbers 59191159 & 59191164 Refs: #2012-02 Attention: For distribution
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What is urgent field safety notice?
Urgent field safety notice is a notification sent to report serious safety concerns or product defects that could potentially harm patients or users.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and importers of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices can be filled out by providing detailed information about the safety concern, the affected product, and any available corrective actions.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to ensure timely communication and action regarding potential safety risks associated with medical devices.
What information must be reported on urgent field safety notice?
Urgent field safety notices must include information about the identified safety concern, the affected device(s), and any recommended actions to be taken by users or healthcare professionals.
When is the deadline to file urgent field safety notice in 2023?
The specific deadline for filing urgent field safety notices in 2023 may vary. It is recommended to refer to the applicable regulations or guidelines for the exact deadline.
What is the penalty for the late filing of urgent field safety notice?
The penalties for late filing of urgent field safety notices can vary depending on the jurisdiction and applicable regulations. It is advisable to consult legal experts or relevant authorities for accurate information.
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