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Class 2 Device Recall Frontal Apron Velcro Closure |
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Date Initiated by Firm |
June 07, 2019 |
Date Posted |
July 30, 2019 |
Recall Status1 |
Terminated 3 on April 28, 2023 |
Recall Number |
Z-2108-2019 |
Recall Event ID |
83144 |
Product Classification |
Apron, leaded - Product Code EAJ
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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.
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Code Information |
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 |
Recalling Firm/ Manufacturer |
Burlington Medical, LLC PO Box 3194 3 Elmhurst St Newport News VA 23603-1137
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For Additional Information Contact |
John Daspit 757-968-5846
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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.
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FDA Determined Cause 2 |
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 |
104 |
Distribution |
US Nationwide distribution.
The products were distributed to the following foreign countries: Korea, Thailand. |
Total Product Life Cycle |
TPLC Device Report
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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.
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