Home › Electrochemical Oxygen Concepts, Inc. › OxySpur® Oxygen Diffusion Dressing
OxySpur® Oxygen Diffusion Dressing
Electrochemical Oxygen Concepts, Inc. · Model 5" x 7" Non-Adhesive · UDI-DI 00851404004091
KPJ
Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are a multi-layer construct with a highly absorbent hydrophilic foam layer directly adjacent to the wound, a highly absorbent hydrophilic foam layer with channels for oxygen distribution, and a super absorbent polymeric laminate, all of which are covered by an occlusive film.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.