medical Class II Updated 2019-08-07

Burlington Medical, LLC recalls Frontal Apron Velcro Closure, Product Number F-17, Part Numb

Recalled Product

Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM 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: 387753 418758 414016 391249 381983 418764 381922 382933 382905 418853 387833 387759 423728 387770 387822 418760 418772 418762 418763 381759 414197 387955 443477 391067 418826 391060 387776 387777 387821 387758 387780 387769 387754 387824 387825 387826 423927 391167 387790 387182 391129 418883 442325 387838 359614 423723 443487 385516 381988 440775 384395 381987 381989 387227 418861 391057 443280 443272 443297 443298 419544 418943 387980 387823 423993 387818 384356 387174 444307 403409 440808 403707 410471 403144 440783 440810 405598 391103 382954 423708 387768 385674 419916 418941 423715 403737 423733 382889 381921 382984 391061 414010 418858 443292 385515 385522 387167 387239 387982 387752 418833 418958 418807 423861
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