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This document informs customers about a voluntary recall of specific lot numbers of Vascular Catheters due to potential packaging particulate matter. It provides instructions for checking inventory,

How to fill out medical device recall

How to fill out Medical Device Recall

1. Identify the specific medical device that needs to be recalled.
2. Gather detailed information about the reasons for the recall.
3. Complete the Medical Device Recall Report form with necessary details.
4. Provide identification information including device name, lot number, and expiration date.
5. State the nature of the defect and potential risks to health.
6. Outline the corrective actions being taken.
7. Ensure all relevant stakeholders are notified, including distributors and healthcare providers.
8. Submit the completed recall report to the appropriate regulatory authority.

Who needs Medical Device Recall?

1. Manufacturers of medical devices that pose a risk to patient safety.
2. Healthcare facilities using the affected medical devices.
3. Distributors and suppliers of medical devices.
4. Regulatory authorities monitoring medical device safety.

People Also Ask about

What does recall refer to?

The verb recall means to remember something. Recall is also used as a verb to mean to request a person to return somewhere. It is used as a noun to refer to an order by a company or manufacturer for a product to be returned for some reason, especially a defect.

What is a medical recall?

A recall of a medicine is an action initiated by a company, either voluntarily or as required by regulatory authorities, to remove a defective pharmaceutical from the market. Additionally, this action includes giving a warning to patients and consumers about the pharmaceutical's potential risks.

What is a recall in medical devices?

A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, an artificial hip) is recalled, it does not always have to be explanted from patients.

What is a recall in medical terms?

A Recall is a type of flag recorded against a patient's record, designed to inform practitioners and/or practice staff of when the patient is due to return to the practice, usually so that some clinical procedure can be performed, such as an annual health check, or a Cervical Screening, for example.

What does recall mean in health?

A patient recall is when a Trust or Hospital contacts people who have previously received treatment to ask them to come in again to be re-examined.

What does recall mean in medicine?

A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk. The list below includes voluntary drug recalls in which public notification has been issued. Visit FDA's role in drug recalls for more information.

What is a product recall in English?

A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker or seller at risk of legal action.

What are the 3 classes of recalls?

While both the FDA and USDA have their own definitions of product recall classes, they follow the same general rule – 1= most serious / dangerous, 2= potentially dangerous and 3 = least dangerous.

For pdfFiller’s FAQs

What is Medical Device Recall?

A medical device recall is a process initiated by a manufacturer or regulatory authority to withdraw a medical device from the market due to safety or efficacy concerns. It aims to protect patients and healthcare providers from potential harm associated with the use of the recalled device.

Who is required to file Medical Device Recall?

Manufacturers, importers, and specific distributors of medical devices are required to file a medical device recall. They must notify the appropriate regulatory authorities about the recall and take necessary actions to withdraw the device from the market.

How to fill out Medical Device Recall?

To fill out a medical device recall, you should begin by providing details about the device, including its name, model number, and the reason for the recall. Include information on the scope of the recall, affected lots, and distribution details. Next, outline the corrective actions to be taken and provide timelines for the recall process.

What is the purpose of Medical Device Recall?

The purpose of a medical device recall is to protect patients from unsafe or ineffective products, ensure that healthcare providers have accurate information about the devices they use, and maintain the integrity of the healthcare system by promptly addressing issues with medical devices.

What information must be reported on Medical Device Recall?

The information that must be reported on a medical device recall includes the device name, model and lot numbers, reason for the recall, specific adverse events associated with the device, quantities distributed, recipient details, and any corrective actions taken. Additionally, the recall notification must outline the steps users should take regarding the recalled device.