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Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, R...

FDA Device Recall #Z-2108-2019 — Class II — June 7, 2019

Recall Summary

Recall Number Z-2108-2019
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 104

Product Description

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.

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: 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

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-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
Z-2113-2019 Class II Vest, Single Item, Product Number Vest, Part Nu... 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.

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