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TruMedical Solutions, LLC. Safety Data Sheet Tru Ultrasound LotionSection 1: Identification Product Name: Tru Ultrasound Lotion Revision Date: 05/27/16 Version#: 01 CAS#: Product is nonhazardous Reorder#:
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How to fill out medical device recalls
How to fill out medical device recalls
01
Identify the affected medical device by serial number, lot number or model number.
02
Determine the reason for the recall, whether it is due to a malfunction, defect or other safety concern.
03
Notify relevant regulatory authorities and customers about the recall.
04
Create a plan for replacing or repairing the affected medical devices.
05
Monitor the progress of the recall and ensure all affected devices are accounted for.
Who needs medical device recalls?
01
Manufacturers of medical devices who have identified a safety issue with their products.
02
Healthcare providers who have purchased or used the affected medical devices.
03
Regulatory authorities responsible for overseeing medical device safety and recalls.
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What is medical device recalls?
Medical device recalls are actions taken by a manufacturer to remove a product from the market or correct a product that is found to be unsafe, defective, or does not meet regulatory standards.
Who is required to file medical device recalls?
Manufacturers, distributors, and importers of medical devices are required to file recalls with the appropriate regulatory authorities.
How to fill out medical device recalls?
To fill out medical device recalls, submit a detailed report to the regulatory authority, including the device's identification, reason for recall, risk assessment, and steps taken to correct the issue.
What is the purpose of medical device recalls?
The purpose of medical device recalls is to protect public health by removing or correcting devices that may pose a risk to patients or users.
What information must be reported on medical device recalls?
Information that must be reported includes device identification, description of the problem, health risks, proposed actions, and communication plan to inform affected parties.
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