FDA-Device2019-08-07Class II
Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
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
49
Manufactured in
PO Box 3194, 3 Elmhurst St, Newport News, VA, United States
Products
Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2127-2019Don't want to check this manually?
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