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This document is a notification regarding the recall of the Juggerknot System implants due to potential puncturing of packaging, breaching sterility, and the risk of infection for patients. It instructs

How to fill out urgent medical device recall

How to fill out Urgent Medical Device Recall Notice

1. Begin by indicating the name of the medical device that is being recalled.
2. Clearly outline the reason for the recall, including any potential risks to patient safety.
3. Include the specific model or lot numbers affected by the recall.
4. Provide detailed instructions on what the recipients should do with the recalled devices, such as return or disposal procedures.
5. Specify the timeline for implementing the recall and any deadlines for compliance.
6. Offer contact information for the responsible party who can answer questions regarding the recall.
7. Ensure the notice is written in clear, straightforward language to avoid confusion.

Who needs Urgent Medical Device Recall Notice?

1. Healthcare providers who use the medical device.
2. Patients who have received treatments or procedures involving the device.
3. Regulatory agencies monitoring medical device safety.
4. Distributors and retailers of the medical device.
5. Service personnel responsible for maintaining the equipment.

People Also Ask about

How do you notify the FDA of a recall?

The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal . If there is not a "risk to health" involved, a report to FDA is not required, but the manufacturer or importer must keep a record of the correction or removal.

How do I contact the FDA about a recall?

Call 1-888-INFO-FDA (1-888-463-6332).

What happens when a medical device is recalled?

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 notification letter of product recall?

A notification letter of product recall is a formal way to inform customers, distributors, or stakeholders about a safety or quality issue with a product. This letter communicates the recall details, the steps being taken to address the issue, and instructions for affected parties, ensuring transparency and trust.

How do I write a recall notice?

This recall has been initiated due to [describe problem and how it was discovered]. [Use/Consumption] of this product may [describe any potential health hazard]. This product was shipped between [range of distribution dates] or This product was shipped to you on [date].

How do I notify the FDA of a recall?

E-mail: We encourage you to submit your report via e-mail to your FDA's Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC) listed here by state or region (look for Product Type "Medical Device"). Foreign manufacturers and importers must e-mail the report to the DRC where their US agent is located.

For pdfFiller’s FAQs

What is Urgent Medical Device Recall Notice?

An Urgent Medical Device Recall Notice is an official communication issued when a medical device is found to pose a risk to health or safety and needs to be removed from the market or corrected.

Who is required to file Urgent Medical Device Recall Notice?

Manufacturers, importers, and distributors of medical devices are required to file an Urgent Medical Device Recall Notice when they determine that a device poses a risk to patients.

How to fill out Urgent Medical Device Recall Notice?

To fill out an Urgent Medical Device Recall Notice, you need to provide details such as the specific device involved, the reason for the recall, actions recommended for affected users, and contact information for further inquiries.

What is the purpose of Urgent Medical Device Recall Notice?

The purpose of the Urgent Medical Device Recall Notice is to inform healthcare professionals and the public about the potential risks associated with certain medical devices, ensuring that corrective actions are taken to protect patient safety.

What information must be reported on Urgent Medical Device Recall Notice?

The information that must be reported includes the device details (name, model, serial numbers), the nature of the risk, details of the recall action, and any instructions for healthcare professionals and patients on how to proceed.