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Date URGENT FIELD SAFETY NOTICE: RA2012-124 Dear Customer Description: TEFLON TUBE T2 HUMERUS, STERILE Catalog # and Lot # Manufacturer Part Number 18060073S Teflon Tube T2 Humerus, sterile Lot# K123596
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What is an urgent field safety notice?
An urgent field safety notice is a notification that is sent to inform the relevant authorities and users of a medical device about a safety issue or risk associated with the device, which requires swift action to ensure patient safety.
Who is required to file an urgent field safety notice?
The manufacturer, distributor, or authorized representative of the medical device is generally required to file an urgent field safety notice when a safety issue is identified that necessitates immediate action.
How to fill out an urgent field safety notice?
An urgent field safety notice should include information such as device details, description of the safety issue, recommended actions, contact details for further inquiries, and any supporting documents. The specific format and requirements may vary depending on the regulatory authority.
What is the purpose of an urgent field safety notice?
The purpose of an urgent field safety notice is to quickly and effectively communicate critical safety information about a medical device to the appropriate stakeholders, including regulatory authorities, healthcare professionals, and patients.
What information must be reported on an urgent field safety notice?
An urgent field safety notice should typically include information such as the device's identification details, a detailed description of the safety issue, potential risks to patients or users, recommended actions to address the issue, and contact information for further inquiries or reporting.
When is the deadline to file an urgent field safety notice in 2023?
The specific deadline to file an urgent field safety notice in 2023 would depend on the regulations and requirements set by the relevant regulatory authority. It is advisable to consult the applicable guidelines or contact the authority directly for specific deadlines.
What is the penalty for the late filing of an urgent field safety notice?
Penalties for the late filing of an urgent field safety notice may vary depending on the jurisdiction and the severity of the non-compliance. Possible penalties could include fines, product recalls, suspension of market authorization, or other regulatory actions. It is important to comply with the applicable regulations and file the notice within the specified deadline.
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