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OxySpur® lite Oxygen Diffusion Dressings
Electrochemical Oxygen Concepts, Inc. · Model 2" x 10" Adhesive · UDI-DI 00851404004121
KPJ
Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
OxySpur® lite Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are constructed with a non-adherent mesh layer directly adjacent to the wound, one lite absorbent hydrophilic foam layer with channels for oxygen distribution, covered by an occlusive film, and an adhesive border. The OxySpur® lite is to be used on wounds with minimal to low exudate, such as later in the wound healing cycle when wound exudate levels decrease.
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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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.