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URGENT MEDICAL DEVICE RECALL ACTION REQUIRED Field Corrective Action #135 Product: DPT SystemModel Numbers: PXAVMP3 Lot Numbers: 61547359 Aug 05, 2019 Customer # Contact name or Dept. Firm Name Attention:
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How to fill out urgent medical device recall
How to fill out urgent medical device recall
01
Identify the urgent medical device recall notification from the manufacturer or regulatory agency.
02
Review the notification for detailed instructions on how to fill out the form.
03
Gather all necessary information about the recalled device, including serial number, lot number, and date of purchase.
04
Fill out the form accurately and completely, making sure to include all required information.
05
Submit the completed form according to the instructions provided in the notification.
Who needs urgent medical device recall?
01
Medical facilities and healthcare providers who have purchased or used the recalled device.
02
Patients who have been treated with the recalled device.
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What is urgent medical device recall?
An urgent medical device recall is initiated when there is a serious risk to health or safety associated with a medical device.
Who is required to file urgent medical device recall?
Manufacturers, distributors, and importers of medical devices are required to file urgent medical device recalls.
How to fill out urgent medical device recall?
Urgent medical device recalls can be filled out by submitting a form to the appropriate regulatory agency responsible for medical devices.
What is the purpose of urgent medical device recall?
The purpose of urgent medical device recall is to remove or correct medical devices that pose a risk to health or safety from the market.
What information must be reported on urgent medical device recall?
Information such as the reason for the recall, affected product details, distribution information, and actions to be taken by the recipients must be reported on urgent medical device recalls.
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