Get the free URGENT MEDICAL DEVICE RECALL - hsa.gov.sg

May 18, 2018, To:Risk Managers and SurgeonsSubject:URGENT MEDICAL DEVICE RECALLAffected Product: Biome Primary Tibial Modular Tray Item Number Lot Numbered Description141215385340(01)00880304005310(17)280306(10)385340Biomet

How to fill out urgent medical device recall

How to fill out urgent medical device recall

1. Step 1: Gather all the necessary information related to the urgent medical device recall, such as product details, lot numbers, and recall notice.
2. Step 2: Identify the affected medical devices and their locations.
3. Step 3: Notify the responsible personnel or departments who are in charge of handling recalls.
4. Step 4: Provide clear instructions on how to document and track the recalled devices, including any required forms or templates.
5. Step 5: Communicate the recall to healthcare professionals, patients, and any relevant stakeholders, using appropriate channels like email, phone calls, or official announcements.
6. Step 6: Follow up with the recipients to ensure they have received and understood the recall information.
7. Step 7: Monitor the progress of the recall process, addressing any issues or concerns that arise.
8. Step 8: Keep records of all actions taken during the recall process for future reference and auditing purposes.
9. Step 9: Close the recall process once all the necessary actions have been completed and the issue has been resolved.

Who needs urgent medical device recall?

1. Manufacturers of medical devices who have identified a defect or potential risk in their products.
2. Distributors and suppliers who have received the affected medical devices and need to take necessary actions to recall them.
3. Healthcare professionals who have utilized or prescribed the medical devices to patients and need to inform them about the recall.
4. Patients who have received the medical devices and need to be aware of the recall in order to take appropriate actions.

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What is urgent medical device recall?

Urgent medical device recall is the immediate removal of a medical device from the market when there is a risk of serious harm or death.

Who is required to file urgent medical device recall?

Manufacturers, importers, and distributors of medical devices are required to file urgent medical device recall.

How to fill out urgent medical device recall?

To fill out urgent medical device recall, the responsible party must provide detailed information about the device, the reason for the recall, and the actions being taken.

What is the purpose of urgent medical device recall?

The purpose of urgent medical device recall is to prevent harm to patients and healthcare providers by removing or correcting devices that pose a risk.

What information must be reported on urgent medical device recall?

Information such as the reason for the recall, affected product codes, distribution dates, and corrective action plans must be reported on urgent medical device recall.