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KCI USA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 6203 FARINON DR., SAN ANTONIO, TX, 78249
Website: mmm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)228-3957
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005178245
DUNS Number: 102726734

Catalogue (240)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
3M™ Snap™	STPAM	FDA UDI	Class II	Active
Solventum US LLC	STPASEE	FDA UDI	Class II	Active
Prevena Plus™ Peel & Place™	PRE3201US	FDA UDI	Class II	Active
3M™ Snap™	STPALP	FDA UDI	Class II	Active
3M™ Veraflo™	ULTVCC05LG	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275081/5 M8275081/10	FDA UDI	Class II	Active
3m™ V.a.c.®	M8275058/10V013	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275042/5 M8275042/10	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275052/5 M8275052/10	FDA UDI	Class II	Active
Abthera Advance™	ABT1055	FDA UDI	Class II	Active
Prevena Restor Roto•form™	PRE5601	FDA UDI	Class II	Active
Prevena Plus™	PRE4010	FDA UDI	Class II	Active
PREVENA RESTOR(TM) Incision Management System	K181507	FDA 510(k)	Class II	Active
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System	K180855	FDA 510(k)	Class II	Active
V.a.c. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress	K133276	FDA 510(k)	Class II	Active
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing	K150006	FDA 510(k)	Class II	Active
ACTIV.A.C. Therapy Unit	K183543	FDA 510(k)	Class II	Active
V.a.c. Ats Large (1000 Ml) Canister With Gel, Models M6275093/5, M6275093/10	K063426	FDA 510(k)	Class II	Active
V.A.C. DERMATAC Drape	K181505	FDA 510(k)	Class II	Active
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack	K153199	FDA 510(k)	Class II	Active
ACTIV.A.C. Negative Pressure Wound Therapy System	K201571	FDA 510(k)	Class II	Active
Vac Therapy System, Models 340000, M8259999, 320000, M8259968 And 320100	K091585	FDA 510(k)	Class II	Active
V.a.c. Freedom Canister, Model M6275421; V.a.c. Ats Canister, Models K6275422, M6275423	K063590	FDA 510(k)	Class II	Active
Prevena Incision Management System	K100821	FDA 510(k)	Class II	Active
Modification To: V.a.c. Granufoam Silver Protection Dressing	K053627	FDA 510(k)	Class II	Active
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	K160487	FDA 510(k)	Class II	Active
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)	K241134	FDA 510(k)	Class II	Active
Kci Npwt Gauze Dressing	K123507	FDA 510(k)	Class II	Active
V.a.c. Via Negative Pressure Wound Therapy System	K132741	FDA 510(k)	Class II	Active
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System	K173426	FDA 510(k)	Class II	Active
Abthera Open Abdomen Dressing, Model: M8275026	K090489	FDA 510(k)	Class II	Active
V.A.C. DERMATAC Drape	K200390	FDA 510(k)	Class II	Active
V.a.c. Therapy Systems - Info V.a.c. Therapy Uniy, Model M6257766	K063740	FDA 510(k)	Class II	Active
V.a.c. Therapy Systems-Acti V.a.c. Therapy Unit Model# 340000	K063692	FDA 510(k)	Class II	Active
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)	K190697	FDA 510(k)	Class II	Active
Activac Therapy Unit And Infovac Therapy Unit, Vac Ats Therapy Unit And Vac Freedom Therapy Unit, Vac Via Therapy Unit	K120033	FDA 510(k)	Class II	Active
V.a.c. 125 Negative Pressure Wound Therapy Unit	K111280	FDA 510(k)	Class II	Active
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit	K173447	FDA 510(k)	Class II	Active
PREVENA 125 and PREVENA PLUS 125 Therapy Units	DEN180013	FDA 510(k)	Class II	Active
Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510	K083357	FDA 510(k)	Class II	Active

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FDA Recalls (30)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 17, 2025	Z-1176-2025	—	open, classified	Due to increase in complaints related to leak alarms
Jan 17, 2025	Z-1175-2025	—	open, classified	Due to increase in complaints related to leak alarms
Nov 5, 2024	Z-0507-2025	—	open, classified	Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Jun 8, 2020	Z-2542-2020	—	terminated	The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Apr 28, 2017	Z-2171-2017	—	terminated	Potential sterile barrier breach
Nov 25, 2015	Z-0600-2016	—	terminated	There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Nov 19, 2014	Z-0933-2015	—	terminated	KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
Sep 18, 2014	Z-0070-2015	—	terminated	A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
May 19, 2014	Z-2717-2014	—	terminated	Blade can shift during shipping which makes the product ineffective.
Jan 30, 2014	Z-1136-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1141-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1135-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1142-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1139-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1137-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1138-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Jan 30, 2014	Z-1140-2014	—	terminated	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Sep 17, 2012	Z-2466-2012	—	terminated	KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow
Jun 27, 2012	Z-0409-2013	—	terminated	The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Apr 6, 2012	Z-1431-2012	—	terminated	The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
Feb 18, 2011	Z-2182-2011	—	terminated	Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
Sep 9, 2010	Z-0611-2011	—	terminated	Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
Nov 4, 2009	Z-0667-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Nov 4, 2009	Z-0663-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Nov 4, 2009	Z-0662-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Nov 4, 2009	Z-0664-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Nov 4, 2009	Z-0666-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Nov 4, 2009	Z-0665-2010	—	terminated	Power cords may crack and fail inside plug with potential for fire hazard.
Jul 29, 2008	Z-2439-2008	—	terminated	The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
Jul 29, 2008	Z-2440-2008	—	terminated	The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.