Events

Recall of 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
    26188
  • Event Risk Class
    Class 2
  • Event Number
    Z-0828-03
  • Event Initiated Date
    2003-04-30
  • Event Date Posted
    2003-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27319
  • 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
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • Reason
    Sterility compromised - incomplete sterile package seal.
  • Action
    The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.

Device

Dr. Fog
  • Model / Serial
    Lot 2005-02-17. Exp. February 2005.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Japan and United Kingdom.
  • Product Description
    Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

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