2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVKF, REFVKM, REFVKB, REFVKD, REFVKE, REFVKF, SEFVKF, SEFVKM, 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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 7, 2019 Burlington Medical Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Burlington Medical, LLC
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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