Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, R...
FDA Device Recall #Z-2119-2019 — Class II — June 7, 2019
Recall Summary
| Recall Number | Z-2119-2019 |
| 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 | 210 |
Product Description
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R 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: 419121 443916 408275 419300 419026 418172 418354 418174 418350 418362 418357 414627 418364 418363 418176 418358 418353 418352 418351 418349 418355 418359 418171 418175 418356 379202 418360 383132 414631 419298 408499 408495 429803 408423 408355 383130 424076 378575 378519 427547 419022 419028 419021 383160 414632 408413 408277 419024 383332 376923 378521 378520 383131 379205 419116 415973 409388 409389 408429 408418 422377 379201 379207 409387 409390 379199 414630 414629 418345 418361 418344 418438 418431 418177 443920 440828 433315 379161 379213 414834 441233 443685 407663 408415 408426 408425 408424 433368 441226 408496 418346 443682 433337 418407 383348 383347 414625 422460 414624 414635 383158 419379 419120 408416 418405 419377 383349 419375 383129 383126 419380 414831 414626 424075 383263 414634 383062 414633 379162 379227 379224 408278 441210 418410 383157 419299 408500 409998 418182 419378 388168 419025 420496 379203 379200 440827 441231 409999 383155 383156 383128 383127 419111 388169 378522 383133 383125 383350 419056 419027 433360 383161 414835 388171 440824 433311 441125 427541 443683 443674 441198 441055 415974 431461 408279 408276 418452 418448 441197 418180 424963 419374 433312 408422 379225 419118 419297 414832 408280 379206 441232 443676 418181 383162 414833 422374 418178 443675 441227 443677 443678 433316 443671 408383 418348 418347 383061 443684 419023 419376 419117 379226 379214 418450 440880 407618 378574 378577 378576 415000
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.