Burlington Medical, LLC: 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.

Recall number

Z-2108-2019

Recalling firm

Burlington Medical, LLC

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.

Status

Terminated

Initiated

2019-06-07

Posted

2019-07-30

Terminated

2023-04-28

Reason

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.

Root 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

104

Distribution

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

EAJ

Firm FEI

1000120804

Firm city

Newport News

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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