UNO 30 Therapy Kit 15x15
GENADYNE BIOTECHNOLOGIES INC. · Model U-S1515-6 · UDI-DI 00849405011644
Description
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | KCI USA, INC. | Due to increase in complaints related to leak alarms |
| 2024-11-05 | KCI USA, INC. | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
| 2024-10-02 | Smith & Nephew Medical, Ltd. | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2020-06-08 | KCI USA, INC. | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2019-12-02 | Medela Inc | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
| 2018-02-07 | Medela Inc | Device may display a battery missing error. |
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