Events

Recall of Device Recall EpiFLO SD

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
    36130
  • Event Risk Class
    Class 2
  • Event Number
    Z-1526-06
  • Event Initiated Date
    2006-03-24
  • Event Date Posted
    2006-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48054
  • 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
    transdermal oxygen therapy device - Product Code KPJ
  • Reason
    Conflicting instructions are provided in the instructions for use (ifu) and the clinical users guide (cug) which accompany the epiflo device. consequently, the firm removed the cug from distribution.
  • Action
    Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.

Device

Device Recall EpiFLO SD
  • Model / Serial
    A total of 18 lot codes were distributed. They are as follows: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
  • Product Description
    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
  • Manufacturer
    Ogenix Corporation

Manufacturer

Ogenix Corporation
  • Manufacturer Address
    Ogenix Corporation, 23230 Chagrin Blvd, Suite 950, Cleveland OH 44122-5461
  • Source
    USFDA