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Hyperbox System
AOTI LIMITED · Model Hyperbox Homecare System · UDI-DI 05391518749990
KPJ
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
The Hyper-Box Homecare System is intended to be used for the treatment of acute and chronic wounds, such as; o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions o decubitus ulcers o amputations/infected stumps o skin grafts o burns o frostbite The device can be used in hospitals, nursing homes, clinics, as well as at the patient's home as an adjunct to standard wound therapy.
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.