Events

Recall of EPIFLO

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

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
    61635
  • Event Risk Class
    Class 2
  • Event Number
    Z-1477-2012
  • Event Initiated Date
    2012-04-16
  • Event Date Posted
    2012-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108599
  • 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
    Chamber, oxygen, topical, extremity - Product Code KPJ
  • Reason
    Ogenix initiated a voluntary recall for the epiflo-15 devices due to a mislabeling of the expiry date for this lot. instead of march 2013, this lot carried may 2013 as the expiry date.
  • Action
    Ogenix sent a letter dated March 16, 2012 to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to confirm the status of the devices and ship product with the recalled lot back to Ogenix and complete the form provided with the letter.

Device

EPIFLO
  • Model / Serial
    AL 041 (only lot involved); model EPIFLO-15.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey.
  • Product Description
    EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. || The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
  • Manufacturer
    Ogenix Corporation

Manufacturer

Ogenix Corporation
  • Manufacturer Address
    Ogenix Corporation, 3401 Enterprise Pkwy, Suite 340, Beachwood OH 44122-7341
  • Manufacturer Parent Company (2017)
    Ogenix Corporation
  • Source
    USFDA