2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM,...
FDA Device Recall #Z-2112-2019 — Class II — June 7, 2019
Recall Summary
| Recall Number | Z-2112-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 7, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Burlington Medical, LLC |
| Location | Newport News, VA |
| Product Type | Devices |
| Quantity | 310 |
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Lot / 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
Other Recalls from Burlington Medical, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2124-2019 | Class II | Frontal Apron with Quick Drop Velcro Closure (n... | Jun 7, 2019 |
| Z-2128-2019 | Class II | Hood, Product Number Hood, Part Numbers HOOD1, ... | Jun 7, 2019 |
| Z-2108-2019 | Class II | Frontal Apron Velcro Closure, Product Number F-... | Jun 7, 2019 |
| Z-2109-2019 | Class II | Frontal Support Belt Apron, Product Number F-15... | Jun 7, 2019 |
| Z-2115-2019 | Class II | Overlap Vest, Single Item, Product Number FVest... | Jun 7, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.