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  4. Industry Guidance For Recalls
  5. Medical Device Model Recall News Release
  1. Industry Guidance For Recalls

Medical Device Model Recall News Release

Note: Text in bold should be modified to reflect appropriate company information

Company Name Issues Nationwide Recall of Product(s) Name(s)

FOR IMMEDIATE RELEASE: Date of News Release
Company Address
Telephone/Company Website

On date of recall initiation, Company Name initiated a nationwide recall of quantity and name of product(s). The product(s) have been found to describe problem, which has/potentially could result in describe public health risk.

State if there is a related recall.

Consumers who have product(s) should stop using/return/replace/throw away/contact their doctor, etc.

Recalled Product(s) was/were manufactured from date to date and distributed from date to date.

The following styles/models/UDI/ID numbers, (etc.) have been recalled:

Name of Product
UDI
Model(s)
Serial Number(s)
Quantity
 

Product(s) can be identified by provide additional details about how product(s) can be identified.

Company Name voluntarily recalled product after becoming aware of fill in. Company Name has notified the FDA of this action.

Brief explanation of what is known about the problem, including the number, type and status of any confirmed injuries--for example, “No injuries have been reported to date.”

Company Name is notifying its distributors and customers by describe method and is arranging for return/replacement/retrofit, etc. of all recalled product(s).

Company Name distributed product(s) to describe type of outlets, states/ geographical area.

Consumers with questions may contact the company via telephone at provide 1-800 number between the hours of x and x (time zone). Consumer may also contact the company via e-mail at e-mail address.

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.

 

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