FDA Device recall Z-2121-2019
Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-… 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-2121-2019 |
| 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, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP 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: 408295 388081 419292 419288 418098 418451 441111 441126 418276 414683 433375 418402 419210…Serial Numbers: 408295 388081 419292 419288 418098 418451 441111 441126 418276 414683 433375 418402 419210 376932 419356 424063 414941 418090 420827 420829 420824 418406 420882 422416 415855 408485 441114 441112 419019 378626 378642 419081 419342 419344 419345 406104 383177 383182 409423 408465 408432 408461 378560 414902 443732 433389 433390 433392 433326 433320 433324 433391 433377 433321 433318 443669 443728 443729 419064 418395 376802 378694 443934 440968 440887 388190 383019 383020 388027 409498 414539 414548 418201 418203 414938 420897 441203 414742 414686 414682 414681 414688 418295 386771 419253 420444 420446 420480 385447 419110 414981 419156 419115 419112 419157 385452 383166 383096 383097 383098 414748 388142 388146 388147 388150 417737 417736 418087 420316 409473 383106 383134 383135 418292 388059 422336 384664 384734 384733 384740 384679 383379 383152 |
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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-2121-2019%22
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