Events

Recall of Device Recall Hand Foot II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by National Biological Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76725
  • Event Risk Class
    Class 2
  • Event Number
    Z-1683-2017
  • Event Initiated Date
    2017-01-27
  • Event Date Posted
    2017-03-20
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154038
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, ultraviolet, dermatological - Product Code FTC
  • Reason
    The wiring may allow the lamps to turn on with the key switch rather than the timer.
  • 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.

Device

Device Recall Hand Foot II
  • Model / Serial
    Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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

Manufacturer

National Biological Corp
  • Manufacturer Address
    National Biological Corp, 23700 Mercantile Rd, Beachwood OH 44122-5900
  • Manufacturer Parent Company (2017)
    National Biological Corporation
  • Source
    USFDA