Kci USA, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
OMP	Negative Pressure Wound Therapy Powered Suction Pump	Class II	General, Plastic Surgery	3	2024-05-23

Date	Severity	Status	Recall #	Product	Code	Reason
2025-01-17	Class II	Ongoing	Z-1176-2025	3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A…	—	Due to increase in complaints related to leak alarms
2025-01-17	Class II	Ongoing	Z-1175-2025	3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US P…	—	Due to increase in complaints related to leak alarms
2024-11-05	Class II	Ongoing	Z-0507-2025	V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an…	—	Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
2020-06-08	Class II	Terminated	Z-2542-2020	ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage:…	—	The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

Date	K-number	Device	Code	Class	Specialty
2024-05-23	K241134	3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)	OMP	Class II	General, Plastic Surgery
2020-07-08	K201571	ACTIV.A.C. Negative Pressure Wound Therapy System	OMP	Class II	General, Plastic Surgery
2020-05-18	K200390	V.A.C. DERMATAC Drape	OMP	Class II	General, Plastic Surgery

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