medical Class II Updated 2019-08-07

Burlington Medical, LLC recalls 2 pc Full Overlap Vest & Kilt, Single Item, Product Number F

Recalled Product

2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM 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: 382915 418869 443152 443303 443314 443116 443309 443122 443190 443115 385698 387994 387972 423969 381793 419868 385687 414095 419532 391154 423565 387997 385699 387917 382841 382946 382824 391134 384324 382787 381796 418843 387119 384454 384420 391099 382998 391096 382816 382909 423746 423667 382819 381798 384421 381821 384336 381828 385580 384349 423530 418903 423531 423976 419873 382859 418830 391146 419862 387967 418955 385691 391138 385680 385532 385692 387900 382782 384402 382823 382818 391163 382857 382866 382838 382906 381939 382995 381808 382903 391091 391164 381807 382862 418886 391148 418885 385690 391088 385681 391086 385682 391088 384412 381917 384422 384394 443131 443310 382900 385600 385693 391136 385683 391080 384294 384425 423945 387969 444689 443128 381790 418894 385686 391135 385684 385731 385689 381942 443104 444591 387974 419843 443129 443300 417565 391145 382850 382931
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