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UNO NPWT 70CC Collection Canister

GENADYNE BIOTECHNOLOGIES INC. · Model U-C070 · UDI-DI 00849405001058

OMP

510(k) clearances

9,186

Adverse events (75 deaths)

Recalls

102

Facilities

Description

The UNO Canister comes in only 1 size, which is 70cc. It has a solidifier gel sheet inside to solidify any collected exudates. The canister is made out of ABS plastic material. At the suction interface, where it is connected to the UNO pump, there is a hydrophobic filter welded to it. The filter has a 0.2 micron pore size, which has a bacteria filtration efficiency (BFE) of over 99%. The UNO canister is a disposable single use item. It comes packaged in a medical grade paper pouch.

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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Data 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.