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60 Middletown Avenue
North Haven, CT 06473
www.medtronic.comURGENT MEDICAL DEVICE RECALL
March 13, 2019,
Attention:Risk Management Director and O.R. Materials ManagementDear Valued Customer:
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01
Gather all necessary information about the patient and the medical device being used.
02
Follow the manufacturer's instructions for filling out the necessary paperwork.
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Who needs and high-risk medical devices?
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High-risk medical devices are typically needed by patients who have complex medical conditions or who require specialized and advanced medical treatments.
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What is and high-risk medical devices?
High-risk medical devices are devices that pose a significant risk to the patient if they malfunction or are used incorrectly.
Who is required to file and high-risk medical devices?
Manufacturers, importers, and distributors of high-risk medical devices are required to file with the appropriate regulatory bodies.
How to fill out and high-risk medical devices?
High-risk medical devices must be filled out with accurate and detailed information regarding the device's design, intended use, performance, and risks.
What is the purpose of and high-risk medical devices?
The purpose of high-risk medical devices is to provide advanced medical treatments and interventions to patients with complex medical conditions.
What information must be reported on and high-risk medical devices?
Information such as the device's classification, intended use, design, performance data, risk analysis, and clinical evaluation must be reported on high-risk medical devices.
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