Below is an excerpt of the Medical Device Recall Notification Letter and Response form template. For correct formatting, Download the formatted Word Doc FDA Medical Device Model Recall Notification Letter and Response form template to freely edit.
Company Name
Date (Month, Day, Year)
URGENT:¹
MEDICAL DEVICE RECALL²
PRODUCT NAME
(1) Attention to Customer:
Customer Name
Device Name
Street Address
City, State, Zip Code
Dear Device Customer/Distributor,
(2) Purpose of this letter
The purpose of this letter is to advise you that Company Name is voluntarily recalling Product X (include the name, intended use statement, and any additional identification detail not covered in the Product and Distribution Information section).
Note: If any serious injuries and/or deaths have occurred or could occur as a result of the failure of the device, add this sentence in bold font: “Serious injuries and/or deaths have occurred or could occur due to the failure mode associated with this recall. We have reports of [number of] deaths and/or[number of] of serious injuries.”
(3) Reason for the Voluntary Recall:
Identify the product concerns/problems, whether actual or potential, in detail (For example, what happens when the device fails). Include the following information, if available:
- Frequency of failures and complaints (for example, “We are aware of [number of] product failures and [number of] complaints associated with the problem.”)
- Magnitude of the error, if applicable (for example, the failure results in values 15% lower than true values)
- Adverse events (that is, injuries, deaths)
¹Recommended for Class I and II recalls. “Urgent” should be noted on both the letter and envelope as per 21 CFR 7.49(4)(b).
² For radiation-emitting electronic products, a recall action is governed by 21 CFR 1004 – Repurchase, Repairs, or Replacement of Electronic Products – under which manufacturers are required to bring such products into conformity with applicable performance standards or correct any reported device defect at no charge to the user. Medical device recalls are governed by 21 CFR 806 – Reports of Corrections and Removals – which does not contain an equivalent requirement.
(4) Risk to Health:
4a) Explain how the device failure or problem will affect patients, health care providers, or other persons who are exposed to the device. If the device failure can cause injuries, delays in surgical procedures, or other delays in treatment or therapy, provide an explanation of why that is so.
4b) Add the statement “How to recognize that the device may fail.” Describe the methods of recognition of the device failure by the customer/user. Give an explanation (in lay terms) of how the failure occurs and how to detect/recognize the issue.
(5) Actions to be taken by the Customer/User:
Describe actions for safe handling of the recalled product (for example: discontinue use, discard or correct the product, return the product, etc.) State whether these actions are temporary or long-term and, if applicable, when a long-term solution will be implemented. At a minimum, ensure that the following elements are included:
- Recommended treatment or actions for users to minimize risks of illness or injury
- Actions to be taken pending corrective or removal action
- Alternative products that can be used, if applicable, and/or whether removal of the product will cause a shortage
- Specific instructions for sub-recall and any associated recalls (for example, private labeling or associated kits, if applicable)
- Instructions for acknowledgement (FAX back, email, telephone, etc.).
(6) Product and Distribution Information: This table is not limited to the information listed below; please insert additional information as applicable. Photographs of the product are optional.
| Product and Distribution Information Table | |||||
| Product Names,
Unique Device Identifier (if applicable) |
Manufacturer’s Product Number/Catalog Number | Lot/Serial Number | Manufacturing/Distribution Dates | Expiration Date (MM/DD/YYYY) | Quantity |
(7) Type of Action by the Company:
What is the firm doing to correct this issue? – (for example, system updates, removal, and change in labeling). When will these corrective actions be taken by the company (short and long-term)?
- Failure Investigation findings:
(8) OTHER INFORMATION:
- Contact information for questions
- Attachments of Acknowledgement and Product Replacement Forms (separate sheets)
Authorized by:
Name: (Print) ____________________________________________________________________________
Signature: ____________________________________________________________________________
Title: ____________________________________________________________________________
Contact Information: Include Days/Hours Available (with Time Zone) for calls such as, Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Add toll-free number if available. Add website information if available.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
MEDICAL DEVICE RECALL RETURN RESPONSE
Acknowledgement and Receipt Form
Response is Required
Customer Information:
Customer Name
Street Address
Town, State, Zip Code
PRODUCT NAME
Lot/Serial numbers:
I have read and understand the recall instructions provided in the <date of> letter. Yes _ No_
Any adverse events associated with recalled product? Yes _ No _
If yes, please explain:
___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Was this device implanted? (If yes, please specify the implant dates, the quantities implanted, and provide available tracking information).
Affected Product Information: Include information that is applicable for affected product.
| Affected Product Information Table | |||||
| Product/Brand Names, UDI ( if applicable) | Manufacturer’s Product Number/Catalog Number | Lot/Serial Number shipped to Customer | Quantity in inventory | Quantity relabeled | Quantity destroyed/ returned |
Return Response Box:
| Please provide any additional information, if applicable.
|
Distributors:
I have checked my stock and have quarantined inventory consisting of _____ <units, cases, etc.>.
I have identified and notified my customers that were shipped or may have been shipped this product by (specify date and method of notification); <or>
Attached is a list of customers who received/may have received this product. Please notify my customers.
Questions: (when applicable)
Please have Customer Service contact me.
Signature of Receipt ________________________
| Name/Title | |
| Telephone | |
| Email address |
PLEASE FAX COMPLETED RESPONSE FORM TO: Tel. # < >, ATTN: < >
OR MAIL TO: FIRM NAME AND ADDRESS