FDA-Device2019-08-07Class II
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Burlington Medical, LLC
Hazard
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Sold states
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Affected count
7
Manufactured in
PO Box 3194, 3 Elmhurst St, Newport News, VA, United States
Products
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2019Don't want to check this manually?
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