Get the free Urgent Medical Device Recall Notification

This document is an urgent notification from Boston Scientific regarding a voluntary product removal of unused inventory of the AMS 700 MS Pump due to complaints about initial activation issues. The letter outlines the steps healthcare providers should take if they have affected devices and stresses the importance of patient safety and compliance with given instructions.

How to fill out urgent medical device recall

How to fill out urgent medical device recall

1. Identify the recalled device and gather all relevant information, including model numbers and reason for recall.
2. Contact the manufacturer or regulatory agency to report the recall and confirm any required actions.
3. Notify all affected healthcare providers or facilities that utilize the device.
4. Provide detailed instructions on how to cease usage and safely return or dispose of the device.
5. Implement a tracking system to monitor the return or corrective actions taken concerning the recalled device.
6. Document all communication and actions taken for compliance and future reference.

Who needs urgent medical device recall?

1. Healthcare providers and facilities that use the medical device.
2. Patients who have received treatment involving the recalled device.
3. Regulatory agencies monitoring device safety and compliance.
4. Manufacturers of the device to ensure corrective actions are implemented.

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What is urgent medical device recall?

An urgent medical device recall is a process initiated to remove a medical device from the market due to a defect or potential risk that could cause serious health consequences.

Who is required to file urgent medical device recall?

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

How to fill out urgent medical device recall?

To fill out an urgent medical device recall, companies must complete a recall report form provided by regulatory authorities, detailing the nature of the recall, affected products, and actions taken.

What is the purpose of urgent medical device recall?

The purpose of an urgent medical device recall is to protect public health by swiftly addressing potential hazards associated with defective medical devices.

What information must be reported on urgent medical device recall?

The report must include device identification details, the reason for recall, risk assessment, affected batches or lots, distribution details, and corrective actions taken.