Z-1683-2017Class II

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

Name: Z-1683-2017 Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For...
Creator: National Biological Corp
Published: 2017-01-27
License: https://open.fda.gov/license/

National Biological Corp. / initiated 2017-01-27 / Terminated / root cause: manufacturing process

FDA source

National Biological Corp began a recall of Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment on 2017-01-27. FDA classified it as Class II and gives the reason as "The wiring may allow the lamps to turn on with the key switch rather than the timer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1683-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-27
Posted: 2017-03-20
Terminated: 2019-02-08
Recalling firm: National Biological Corp.
Product: Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
Product code: FTC Light, Ultraviolet, Dermatological
Reason for recall: The wiring may allow the lamps to turn on with the key switch rather than the timer.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1683-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1683-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

Product code FTC

K872604Class IIHand/foot 624-208National Biological Corp. / cleared 1987-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)