Get the free Product Recall Notice Response Form - mhra gov

This document serves as a response form for a product recall notice regarding the AMPLATZER® TorqVue® 10F 45º Delivery Systems, requesting recipients to report their inventory status.

How to fill out product recall notice response

How to fill out Product Recall Notice Response Form

1. Obtain the Product Recall Notice Response Form from the relevant source, such as the manufacturer's website or a regulatory agency.
2. Carefully read the instructions provided on the form to understand the requirements.
3. Fill in your contact information at the top of the form, including your name, address, phone number, and email.
4. Provide details about the product involved in the recall, including the product name, model number, and any other relevant identifiers.
5. Indicate the quantity of the product you have and whether you have used any of it.
6. Specify any symptoms or issues you experienced with the product, if applicable.
7. Review the information for accuracy before submitting the form.
8. Submit the completed form as instructed, either online, by email, or by mail, depending on the guidelines provided.

Who needs Product Recall Notice Response Form?

1. Consumers who purchased the recalled product and need to report their information.
2. Retailers or distributors of the recalled product who must quarantine or return the inventory.
3. Regulatory agencies requiring feedback for safety monitoring purposes.

People Also Ask about

How do you announce a product recall?

Internet/Email: Press Release or Recall Alert. Website posting on the firm's main website (prominent link to recall information on the main landing page) Blog post on firm's blog or recent product reviewer's blog. Website registration for recall. Stop‐sale notification to all retailers, dealers, distributors, and websites.

What to do when there is a product recall?

Typically, the instructions will indicate that you need to do one of the following: Return the product to the store where you bought it for a refund. Dispose of the product properly so that other people or animals cannot eat it. (This is particularly important if you opened the product.)

How to issue a product recall?

Manufacturers are required to publish a notice in a form and manner that will bring to the attention of purchasers of the product the risk it poses and the facts of the recall. Producers and distributors must inform their local authority (typically, the Trading Standards Department).

How do I notify the FDA of a recall?

You must contact 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 contact the DRC where their US agent is located.

How to 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 you write a recall statement?

Create your recall communications Describe the product including the name, make, model and any distinguishing features, including batch or serial numbers. Give the dates the product was sold. Give clear images of the product and any unique markings to help consumers identify the product.

For pdfFiller’s FAQs

What is Product Recall Notice Response Form?

The Product Recall Notice Response Form is a document used by manufacturers, distributors, and retailers to formally respond to a product recall notice issued by regulatory authorities or manufacturers.

Who is required to file Product Recall Notice Response Form?

Entities that market and sell the affected products, including manufacturers, distributors, and retailers, are required to file the Product Recall Notice Response Form.

How to fill out Product Recall Notice Response Form?

To fill out the Product Recall Notice Response Form, you need to provide details including the recall notice reference number, product identification, reason for the recall and any actions taken to rectify the situation.

What is the purpose of Product Recall Notice Response Form?

The purpose of the Product Recall Notice Response Form is to ensure that relevant parties acknowledge the recall and provide necessary information on how they plan to address the issue, thereby aiding in consumer safety and compliance with regulations.

What information must be reported on Product Recall Notice Response Form?

The information that must be reported includes the product name, product codes, dates of manufacture, details of the defect or safety issue, harm potentially caused, actions taken to mitigate the issue, and contact information of the respondent.