Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to prot...

FDA Device Recall #Z-2127-2019 — Class II — June 7, 2019

Recall Summary

Recall Number Z-2127-2019
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 49

Product Description

Cap, Product Number Cap, Part Numbers CAP1, CAP2 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: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573

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.