Recall Z-1683-2017
National Biological Corp · initiated January 27, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
Codes / lots: Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869
Reason for recall
The wiring may allow the lamps to turn on with the key switch rather than the timer.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-1683-2017
- Initiated
- January 27, 2017
- Posted by FDA
- March 20, 2017
- Terminated
- February 8, 2019
- Product code
- FTC – Light, Ultraviolet, Dermatological
- 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.
- Recalling firm
- National Biological Corp, Beachwood, OH