2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, RE...
FDA Device Recall #Z-2114-2019 — Class II — June 7, 2019
Recall Summary
| Recall Number | Z-2114-2019 |
| 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 | 129 |
Product Description
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM 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: 382915 418869 443152 443303 443314 443116 443309 443122 443190 443115 385698 387994 387972 423969 381793 419868 385687 414095 419532 391154 423565 387997 385699 387917 382841 382946 382824 391134 384324 382787 381796 418843 387119 384454 384420 391099 382998 391096 382816 382909 423746 423667 382819 381798 384421 381821 384336 381828 385580 384349 423530 418903 423531 423976 419873 382859 418830 391146 419862 387967 418955 385691 391138 385680 385532 385692 387900 382782 384402 382823 382818 391163 382857 382866 382838 382906 381939 382995 381808 382903 391091 391164 381807 382862 418886 391148 418885 385690 391088 385681 391086 385682 391088 384412 381917 384422 384394 443131 443310 382900 385600 385693 391136 385683 391080 384294 384425 423945 387969 444689 443128 381790 418894 385686 391135 385684 385731 385689 381942 443104 444591 387974 419843 443129 443300 417565 391145 382850 382931
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.