KPJClass II

Chamber, Oxygen, Topical, Extremity

General, Plastic Surgery · 21 CFR 878.5650

MDR events2All time

Recalls2All time

Registered firms19Currently listed

510(k) clearances23All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

Kobelco Northwest1 Numotech, Inc.1

Recalls

2 recall events for this product code

Ogenix Corporation
TerminatedApr 30, 2012
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Ent
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.
Z-1477-2012 · View FDA record ↗
Ogenix Corporation
TerminatedSep 28, 2006
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 pa
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.
Z-1526-06 · View FDA record ↗

Registered firms

19 firms currently registered for this product code

510(k) clearances

23 clearances for this product code