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Hybrid Dressing
GENADYNE BIOTECHNOLOGIES INC. · Model UP-D1040/5 · UDI-DI 10849405002182
OMP
Prescription
10
510(k) clearances
9,182
Adverse events (75 deaths)
47
Recalls
100
Facilities
Description
Hybrid Dressing 10x40 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
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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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.