Z-1477-2012

EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number...

Name: Z-1477-2012 EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number...
Creator: Ogenix Corporation
Published: 2012-04-16
License: https://open.fda.gov/license/

Omarc LLC / initiated 2012-04-16 / Terminated / root cause: labeling and UDI

FDA source

Ogenix Corporation began a recall of EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401... on 2012-04-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1477-2012
Status: Terminated
Initiated: 2012-04-16
Posted: 2012-04-30
Terminated: 2013-02-19
Recalling firm: Omarc LLC
Product: 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.
Product code: KPJ Chamber, Oxygen, Topical, Extremity
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 38 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey.
Product codes and lots: AL 041 (only lot involved); model EPIFLO-15.

Product code KPJ

K023456Class IIOxybox SystemOxyfast Corporation / cleared 2003-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)