Events

Recall of Vicks

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

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
    26000
  • Event Risk Class
    Class 2
  • Event Number
    Z-0790-03
  • Event Initiated Date
    2003-04-15
  • Event Date Posted
    2003-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26850
  • 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
    Humidifier, Non-Direct Patient Interface (Home-Use) - Product Code KFZ
  • Reason
    Humidifiers may overheat.
  • Action
    Letters dated 4/16/2003 to direct accounts (wholesalers/retail distribution chains) with instructions to quarantine product, notify retail stores, and attempt to notify consumers who purchased the units. Posters will be posted at retail stores where the units were sold.

Device

Vicks
  • Model / Serial
    8-digit code ending in either 2KUO or 3KUO.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed through 32 direct accounts (wholesalers and retail distribution chains) throughout the U.S. The firm estimates between 35,000 and 45,000 units remain in distribution channels; and between 65,000 and 75,000 are in homes.
  • Product Description
    Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.
  • Manufacturer
    KAZ Inc.

Manufacturer

KAZ Inc.
  • Manufacturer Address
    KAZ Inc., One Vapor Trail - 4411 Route 9, Hudson NY 12534
  • Source
    USFDA