Events

Recall of Device Recall Ultracell

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

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
    25224
  • Event Risk Class
    Class 2
  • Event Number
    Z-0480-03
  • Event Initiated Date
    2003-01-08
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25679
  • 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
    Ear Wick - Product Code KCN
  • Reason
    Sterility of the device is compromised.
  • Action
    Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.

Device

Device Recall Ultracell
  • Model / Serial
    Lot Numbers: 063204 Exp. 7/2005  063206 Exp. 8/2005   063207 Exp. 10/2005
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Ultracell Ear Wick 9mm DIA x 15 mm || Catalog #: 30300-C
  • Manufacturer
    Ultracell Medical Technologies

Manufacturer

Ultracell Medical Technologies
  • Manufacturer Address
    Ultracell Medical Technologies, 183 Providence, North Stonington CT 06359
  • Source
    USFDA