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Burlington Medical, LLC recalls Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare work
Recalled August 7, 2019 · FDA recall Z-2128-2019 · Burlington Medical
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. · FDA Class II
Units
3
Sold at
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Description
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.
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.
Manufacturer(s)
Burlington Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →