Events

Recall of Device Recall Dr. Fog

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aspen Surgical Products, 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
    32092
  • Event Risk Class
    Class 2
  • Event Number
    Z-0897-05
  • Event Initiated Date
    2005-05-15
  • Event Date Posted
    2005-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39113
  • 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
    unknown device name - Product Code KOG
  • Reason
    An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
  • Action
    Consignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers.

Device

Device Recall Dr. Fog
  • Model / Serial
    Lot 2007-05-25; exp. May 2007.
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Dr. Fog Endoscopic fog prevention kit.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

Aspen Surgical Products, Inc.
  • Manufacturer Address
    Aspen Surgical Products, Inc., 7425 Clyde Park Ave Sw Ste G, Byron Center MI 49315-8373
  • Source
    USFDA