FDA Device recall Z-2122-2019
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4… by Burlington Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2122-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-07 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Burlington Medical |
| Distribution | US |
Product
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-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
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.
Identifiers
| code_info | Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181…Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181 441139 441136 441130 441131 441135 443748 423654 414987 420870 420877 443626 419123 388250 388245 383021 383032 381507 388123 381663 381508 376803 440957 440956 440966 433273 433267 440958 433270 414813 414814 414836 414837 414838 384534 388075 378637 414934 418310 418308 418302 418307 418303 383136 420902 424097 418102 418336 378749 409409 409435 381660 419139 383147 383145 419275 419274 418368 433348 408393 408010 408390 408316 409467 383081 388121 419246 424109 414884 408307 408322 408317 408313 408344 408330 408377 388248 378630 378638 378581 440846 433424 440842 441224 408308 408305 409448 408320 408310 408311 408323 408303 408312 408315 408306 408309 408340 408314 419043 383023 419074 431097 414823 424013 443695 443660 440979 443666 443651 443652 443648 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2122-2019%22
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