Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1683-2017 · Posted 2017-03-20

Recalling FirmNational Biological Corp
Recall StatusTerminated
Product CodeFTC
Date Initiated2017-01-27
Date Terminated2019-02-08
Product Quantity7 units

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K872604HAND/FOOT 624-208National Biological Corp. · 1987-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑