Class 2 Device Recall 2 pc Full Wrap Vest & Kilt

• Date Initiated by Firm: June 07, 2019
• Date Posted: July 30, 2019
• Recall Status: Terminated on April 28, 2023
• Recall Number: Z-2112-2019
• Recall Event ID: 83144
• Product Classification: Apron, leaded - Product Code EAJ
• Product: 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF; ; 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.
• Code Information: Serial Numbers: 442293 443188 385619 387938 385611 385530 381778 387881 381782 387884 381781 387890 381843 387940 391124 387889 381780 387880 419929 418856 385607 387808 382887 391161 382951 381851 382896 385579 385748 381856 381857 381946 387866 423956 387877 423947 387872 423942 387871 423987 387863 423960 387869 424000 423961 387873 387864 419806 387870 419807 419776 423855 387874 423998 419774 419808 419770 419795 419775 419803 418868 419800 387867 419804 382803 391117 382956 382870 382941 382869 419942 419870 419943 418846 381831 385673 1111384500 382794 419934 418859 385610 385535 385735 385620 385740 385616 385533 385624 418779 387968 418789 418752 384333 382911 382878 382945 382856 382926 381903 381913 381864 391068 414763 418992 382959 382797 387924 418985 414044 423560 414346 414117 417567 419809 442291 443283 387865 418956 423601 384488 385626 385529 385724 387956 382962 379689 419937 418881 385697 418946 423979 391149 385634 381797 385636 387991 387987 387901 381794 387995 387957 418809 387960 418817 387898 418776 387977 418777 381804 418795 391156 418770 391151 418771 385637 387999 381904 385525 419847 387962 418895 387923 382985 382928 381850 381806 381830 381852 381872 391078 385633 385662 385622 385716 385627 385677 419944 419778 384477 384489 419913 423860 419945 419855 391125 381848 444520 443809 444290 443820 443801 443811 443344 426767 419938 423973 419940 418984 381846 387854 391131 385722 391157 382884 387970 388000 391106 385578 382892 385592 387142 387132 384496 387147 384475 384379 384381 384498 382942 384401 391127 385728 391105 382907 382979 382855 443307 443372 382987 384416 382836 382804 382965 391062 391120 382929 443402 443268 443220 443401 443817 443819 443315 442292 442290 443308 444717 444736 443346 427182 382970 387184 382977 382800 382910 382774 391065 382790 382795 382776 382939 382806 391058 382779 387950 419874 385621 385713 387868 418860 382971 384390 385730 391119 442294 443301 443302 442295 443371 443305 444718 443304 381906 381908 391122 387793 381907 391085 385629 385742 387992 391126 382927 382934 385609 387811 382904 385593 419797 423948 414766 418983 387976 419889 391137 387979 381814 385729 419786 419785
• Recalling Firm/ Manufacturer: Burlington Medical, LLC; PO Box 3194; 3 Elmhurst St; Newport News VA 23603-1137
• For Additional Information Contact: John Daspit; 757-968-5846
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters were sent to customers on 6/7/19. Please take the following actions: Cease using recalled products immediately, quarantine the products, and prepare the products for return shipment to Burlington Medical. Contact Burlington Medical at (800) 221-3466 for specific return instructions. Note that Burlington Medical Customer Care will work with you to facilitate the return of recalled products, including by issuing you a Recall Tracking number. Burlington Medical will replace all recalled products at no cost to you. The replacement product will be the same size and model as the recalled product; if the same size and model is not available or has been discontinued, then Burlington Medical will replace the recalled product with a Burlington Medical product that is similar to the recalled product. Our Customer Care team will arrange for free shipment of the replacement product. If you have any questions, please call your Burlington Medical representative or Burlington Medical Customer Care at (800) 221-3466. The recall was expanded an additional Urgent Medical Device Recall notification letters were sent to customers on 7/3/19.
• Quantity in Commerce: 310
• Distribution: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.