medical Class II Updated 2019-08-07

Burlington Medical, LLC recalls Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Prod

Recalled Product

Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 419558 419557 414132
View official government recall

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