FDA Device recall Z-2117-2019
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect h…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect h… 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-2117-2019 |
| 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
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*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: 418892 381887 381902 418811 418952 387916 429678 |
|---|
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-2117-2019%22
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