FDA Device recall Z-2116-2019
2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPV…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPV… 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-2116-2019 |
| 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
2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F 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: 381795 385536 443407 444693 387809 385555 419989 419866 391144 385552 414184 419956 385597…Serial Numbers: 381795 385536 443407 444693 387809 385555 419989 419866 391144 385552 414184 419956 385597 381894 419988 419822 419992 419961 419912 423985 443459 444691 443411 443313 382943 384393 391038 379532 418751 385727 383000 382932 382986 382784 381893 385750 387236 382780 378516 381829 382875 391237 443398 443446 443476 444608 443410 443155 387927 385678 382812 382767 387915 418780 419828 419885 419869 423977 381901 385737 385550 385746 381891 385736 385547 387878 442492 443447 387934 387816 387973 387893 384413 391036 391101 382773 419990 418828 443471 444662 382957 384404 391087 385558 385562 385542 385512 385526 414081 414065 391224 382968 382763 382935 391228 382919 391227 382936 379707 377610 420000 419878 419994 419968 423553 419875 391229 381823 426470 443420 391044 382830 418914 418991 443312 443413 385741 381889 419927 387852 381883 381944 385596 |
|---|
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-2116-2019%22
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