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U.S. Department of Health and Human Services

Class 2 Device Recall EPIFLO

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 Class 2 Recall
EPIFLO
see related information
Date Posted April 30, 2012
Recall Status1 Terminated on February 19, 2013
Recall Number Z-1477-2012
Recall Event ID 61635
Premarket Notification
510(K) Number
K023456 
Product Classification Chamber, Oxygen, Topical, Extremity - Product Code KPJ
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.
Code Information AL 041 (only lot involved); model EPIFLO-15.
Recalling Firm/
Manufacturer
Ogenix Corporation
3401 Enterprise Pkwy
Suite 340
Beachwood, Ohio 44122-7341
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Srinivasan Sarangapani
781-702-6732
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPJ and Original Applicant = OXYFAST CORPORATION
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