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Insert local affiliate or distributor address XX February 2009 Urgent Field Safety Notice Commercial Name of Affected Product: 30/40/50 CC IAB Catheters 30/40/50 CC IAB Volume Connectors FSA Identifier:
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What is teleflex fsndoc - mhra?
Teleflex fsndoc - mhra is a document that needs to be filed with the MHRA (Medicines and Healthcare products Regulatory Agency). It is related to the teleflex fsn (field safety notice) for medical devices.
Who is required to file teleflex fsndoc - mhra?
Manufacturers, authorized representatives, or distributors of medical devices are required to file teleflex fsndoc - mhra with the MHRA.
How to fill out teleflex fsndoc - mhra?
To fill out teleflex fsndoc - mhra, you need to provide information about the medical device, including its identification details, the reason for the field safety notice, actions to be taken, and any additional relevant information. The MHRA provides a specific form for filing this document.
What is the purpose of teleflex fsndoc - mhra?
The purpose of teleflex fsndoc - mhra is to inform the MHRA about any safety issues or concerns regarding a medical device manufactured, distributed, or represented by Teleflex. It ensures that the MHRA is aware of any potential risks associated with the device and can take appropriate actions to protect patient safety.
What information must be reported on teleflex fsndoc - mhra?
Teleflex fsndoc - mhra must include information such as the device's name and model number, the reason for the field safety notice, details of the safety issue or concern, any recommended actions, information about previous similar incidents, and contact details for further communication.
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