The Recall Desk
HighFDA (Devices)·Z-1683-2017·Announced 2017-04-05

National Biological Hand Foot II UVB-138 Phototherapy Devices Recalled for Wiring Defect

National Biological Corp is recalling seven Hand Foot II, UVB-138 phototherapy devices because wiring defects may allow lamps to turn on with the key switch rather than the timer.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could lead to unintended UV exposure, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

National Biological Corp is recalling seven units of the Hand Foot II, UVB-138 device, which is used for UV phototherapy treatment. The recall involves specific serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, and 39869.

The recall was initiated because the device wiring may allow the lamps to turn on with the key switch rather than the timer. This defect could result in unintended operation of the UV lamps.

The affected devices were distributed worldwide, including in the US states of Iowa, Illinois, Michigan, New York, Pennsylvania, and Wisconsin, as well as in Jordan. There are no government, Canadian, or Mexican accounts for this recall. Consumers and healthcare providers should stop using the affected devices and contact National Biological Corp for instructions on repair or replacement.

The recalled product

Product
Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
Manufacturer
National Biological Corp
Category
Medical Device — Phototherapy Equipment
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Serial numbers: 39870
  • 39873
  • 39874
  • 39866
  • 39867
  • 39871
  • 39869

Distribution

Distributed in 6 states:

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