Drug recall
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA recall event 76787 · Class II · 2k Innovations Inc.
Key facts
| Event ID | 76787 |
|---|---|
| Recall numbers | Z-1802-2017, Z-1803-2017, Z-1804-2017, Z-1805-2017, Z-1806-2017, Z-1807-2017, Z-1808-2017, Z-1809-2017, Z-1810-2017, Z-1811-2017, Z-1812-2017, Z-1813-2017 |
| Recalling firm | 2k Innovations Inc. |
| Product type | Devices |
| Products | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps, Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps, Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps, Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps, Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps and 7 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| Initiation date | Apr 15, 2016 |
| Report date | Apr 19, 2017 |
| Termination date | Aug 7, 2019 |
| City | Saint Augustine |
| State | FL |
| Country | United States |
| FEI number | 3010476958 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: