Recall Z-1477-2012 ยท KPJ Chamber, Oxygen, Topical, Extremity
Ogenix Corporation
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.) am
| Date | Apr 30, 2012 (initiated Apr 16, 2012) |
| Status | Terminated |
| 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. |
| 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 | 38 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023456 | OXYBOX SYSTEM Oxyfast Corporation, Feb 24, 2003 |