Class 2 Device Recall 2 pc Full Wrap Vest & Kilt BackSaver

• Date Initiated by Firm: June 07, 2019
• Date Posted: July 30, 2019
• Recall Status: Terminated on April 28, 2023
• Recall Number: Z-2116-2019
• Recall Event ID: 83144
• Product Classification: Apron, leaded - Product Code EAJ
• Product: 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F; ; 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: 381795 385536 443407 444693 387809 385555 419989 419866 391144 385552 414184 419956 385597 381894 419988 419822 419992 419961 419912 423985 443459 444691 443411 443313 382943 384393 391038 379532 418751 385727 383000 382932 382986 382784 381893 385750 387236 382780 378516 381829 382875 391237 443398 443446 443476 444608 443410 443155 387927 385678 382812 382767 387915 418780 419828 419885 419869 423977 381901 385737 385550 385746 381891 385736 385547 387878 442492 443447 387934 387816 387973 387893 384413 391036 391101 382773 419990 418828 443471 444662 382957 384404 391087 385558 385562 385542 385512 385526 414081 414065 391224 382968 382763 382935 391228 382919 391227 382936 379707 377610 420000 419878 419994 419968 423553 419875 391229 381823 426470 443420 391044 382830 418914 418991 443312 443413 385741 381889 419927 387852 381883 381944 385596 381882 381900 385546 419962 423625 418898 418845 419987 423986 419991 419973 384415 382799 382832 382778 419983 423931 419964 387859 418773 418888 443425 444663 387933 387936 382913 382777 382845 382937 381888 385577 385523 385599 418949 419845 423965 418896 391225 387244 418871 423930 387810 385513 419976 423967 418876 418821 419864 423541 381890 385743 419824 418891 381895 382916 423903 419980 391049 384400 423515 419578 426456 429676 385511 391083 382752 382802 443799 443113 444538 443347 385549 385717 387858 387886 382994 382842 387930 418819 419856 418850 423631 414773 391063 391056 387882 418839 418890 379579 443181 443409 391039 384367 444724 443417 385733 381892 385559 385527 382975 382796 385563 385534 385952 384468 418783 418907 418912 418910 418837 418906 418913 418877 384455 382967 385594 391235 443470 444627 391053 382854 387853 418899 382980 382771 418884 423983 418852 419827 414324 414075 385598 382961 419999 418879 414062 414278 418887 387989 391050 382808 382825 382997 391055 382999 384396 391051 385551 418834 382791 384417 381896 381822 444544 426347 418902 418889 387928 387857 418987 419829 385554 387801 419984 423981 423978 419982 418857 419000 443282 443412 443416 443263 443260 443414 443359 443267 443343 429677 441453 441255 441465 441452 381845 385726 382783 391226 418866 418870 387896 418825 391040 382930 418849 418874 387899 418848 419985 423929 418862 418908 385548 387883 418841 423856 423966 418851 403119 443149
• 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: 332
• 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.