Recall Z-1683-2017— National Biological Corp

Name: FDA recall Z-1683-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-27

Class II · Terminated

Class II FDA medical device recall by National Biological Corp, initiated 2017-01-27, terminated 2019-02-08. It names one FDA 510(k) clearance: K872604. Product: Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.. Reason: The wiring may allow the lamps to turn on with the key switch rather than the timer..

Recalling firm: National Biological Corp
Classification: Class II
Status: Terminated
Initiated: 2017-01-27
Terminated: 2019-02-08
Firm location: Beachwood, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K872604 — HAND/FOOT 624-208National Biological Corp.·cleared 1987-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.

Reason for recall

The wiring may allow the lamps to turn on with the key switch rather than the timer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.