EPIFLO®
Ogenix · Model 15-day · UDI-DI 00855526003055
KPJ
Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
Transdermal Continuous O2 Therapy. Oxygen Concentrator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-04-16 | Ogenix Corporation | 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 d |
| 2006-03-24 | Ogenix Corporation | 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 |
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