Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
This recall has been terminated (originally issued March 20, 2017).
- Company
- National Biological Corp
- Recall Initiated
- January 27, 2017
- Posted
- March 20, 2017
- Terminated
- February 8, 2019
- Recall Number
- Z-1683-2017
- Quantity
- 7 units
- Firm Location
- Beachwood, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The wiring may allow the lamps to turn on with the key switch rather than the timer.
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.
Lot / Code Info
Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869
Root 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.
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