Recall Z-1683-2017 ยท FTC Light, Ultraviolet, Dermatological
National Biological Corp
Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
| Date | Mar 20, 2017 (initiated Jan 27, 2017) |
| Status | Terminated |
| Reason | The wiring may allow the lamps to turn on with the key switch rather than the timer. |
| Root cause | Employee error |
| Action | Individual patients were contacted via telephone. Replacement devices have been distributed. The distributor was contacted via email. The firm has requested that consignees return the recalled device to their firm to be held under quarantine. |
| Quantity | 7 units |
| Distribution | Worldwide distribution. US states: IA, IL, MI, NY, PA, and WI. Country: Jordan. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872604 | HAND/FOOT 624-208 National Biological Corp., Jul 24, 1987 |