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URGENT Medical Device Recall
7/18/2019
Dear Valued Customer,
This is to inform you that Gen therm Medical, LLC (formerly Cincinnati Subzero) is conducting a voluntary
product recall involving:
NormOTemp
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How to fill out medical device recall electri-cool
How to fill out medical device recall electri-cool
01
Gather all necessary information such as the device information, lot number, and reason for the recall.
02
Contact the appropriate regulatory authorities to report the recall.
03
Notify customers and users of the device about the recall and provide instructions on how to return the device.
04
Keep detailed records of the recall process including communications and any corrective actions taken.
Who needs medical device recall electri-cool?
01
Medical device manufacturers, distributors, and users who have identified issues with the electri-cool device that pose a safety risk.
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What is medical device recall electri-cool?
Medical device recall electri-cool is a process initiated by the manufacturer or distributor to remove or correct a medical device that is in violation of laws or regulations.
Who is required to file medical device recall electri-cool?
Manufacturers and distributors of medical devices are required to file medical device recall electri-cool.
How to fill out medical device recall electri-cool?
Medical device recall electri-cool can be filled out by providing information about the device, reason for recall, potential health risks, and corrective actions.
What is the purpose of medical device recall electri-cool?
The purpose of medical device recall electri-cool is to protect public health and safety by removing or correcting devices that may pose a risk.
What information must be reported on medical device recall electri-cool?
Information such as device description, reason for recall, quantity affected, distribution information, and contact information must be reported on medical device recall electri-cool.
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