Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV photothe
FDA device recall Z-1683-2017 · posted 2017-03-20 · Terminated
Recall details
- Recalling firm
- National Biological Corp
- Reason for recall
- The wiring may allow the lamps to turn on with the key switch rather than the timer.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FTC
- Quantity affected
- 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 acco
- Date initiated
- 2017-01-27
- Date posted
- 2017-03-20
- Date terminated
- 2019-02-08
- Location
- Beachwood, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAND/FOOT 624-208 (K872604) | National Biological Corp. | 1987-07-24 |