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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Prevena™ Peel & Place™	Prevena Peel & Place Dressing- 20 cm	FDA UDI	Class II	Active
V.a.c. Whitefoam™	M8275067/5	FDA UDI	Class II	Active
V.a.c.® Simplace™	M8275040/5 M8275040/10	FDA UDI	Class II	Active
V.a.c.®	M6275066/5 M6275066/10	FDA UDI	Class II	Active
Prevena Restor™ Arthro•form™	PREVENA RESTOR™ ARTHRO•FORM™	FDA UDI	Class II	Active
3M™ Veraflo™	ULTVCC05MD	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275042/5 M8275042/10	FDA UDI	Class II	Active
V.a.c.®	M8275080/5	FDA UDI	Class II	Active
V.a.c.®	M6275069/5 M6275069/10	FDA UDI	Class II	Active
Abthera™	370620	FDA UDI	Class II	Active
DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING	DTGF10PKM	FDA UDI	Class II	Active
Prevena Restor™ Bella•form™	PREVENA RESTOR™ BELLA•FORM™	FDA UDI	Class II	Active
V.A.C. Freedom™	FRE-KIT	FDA UDI	Class II	Active
3M™ V.A.C.® Granufoam™	M8275053/5 M8275053/10	FDA UDI	Class II	Active
Prevena Restor Axio•form™	PRE5555	FDA UDI	Class II	Active
3M™ V.A.C. Veraflo Cleanse™	ULTVCL05MD	FDA UDI	Class II	Active
V.A.C. VERAFLO Cleanse Choice™	ULTVCC05LG	FDA UDI	Class II	Active
V.a.c. Whitefoam™	M8275068/5	FDA UDI	Class II	Active
Activ.a.c.™	M8275058/5 M8275058/10	FDA UDI	Class II	Active
DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING	DTGF10PKS	FDA UDI	Class II	Active
Prevena Restor™ Arthro•form™	PREVENA RESTOR™ ARTHRO•FORM™	FDA UDI	Class II	Active
Abthera™	370605	FDA UDI	Class II	Active
Dermatac™ Film	DTAC10FLM	FDA UDI	Class I	Active
V.a.c.® Granufoam™	M8275065/5	FDA UDI	Class II	Active
Activ.a.c.™	M8275058/5 M8275058/10	FDA UDI	Class II	Active
V.a.c.® Simplace™	M8275041/5 M8275041/10	FDA UDI	Class II	Active
3M™ Snap™	STPAS	FDA UDI	Class II	Active
3M™ Prevena Restor™ Adaptiform™	PRE6001	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275081/5 M8275081/10	FDA UDI	Class II	Active
Infov.a.c.™	M8275071/5 M8275071/10	FDA UDI	Class II	Active
Prevena Restor™ Bella•form™	PREVENA RESTOR™ BELLA•FORM™	FDA UDI	Class II	Active
V.a.c.rx4	RX4DEV01/US	FDA UDI	Class II	Active
V.a.c. Simplicity™	414773	FDA UDI	Class II	Active
Solventum US LLC	STPAL	FDA UDI	Class II	Active
Snap™	SNPA100US	FDA UDI	Class II	Active
Prevena™ Peel & Place™	PRE1101US	FDA UDI	Class II	Active
V.a.c. Ats™	M6275063/5 M6275063/10	FDA UDI	Class II	Unknown
Snap™	Snap Securring	FDA UDI	Class II	Active
V.A.C.® GRANUFOAM™ Silver™	M8275098/5 M8275098/10	FDA UDI	Class II	Active
V.a.c.® Simplace™	M8275041/5 M8275041/10	FDA UDI	Class II	Active
Solventum US LLC	ABT1055	FDA UDI	Class II	Active
V.a.c.® Granufoam™	M8275075/5 M8275075/10	FDA UDI	Class II	Unknown
V.a.c.® Granufoam™	M8275075/5 M8275075/10	FDA UDI	Class II	Active
V.a.c.via™ Granufoam™	VIAGFM05	FDA UDI	Class II	Active
Prevena Duo™ Peel & Place™	PRE1121US	FDA UDI	Class II	Active
V.a.c. Freedom™	320058/5 320058/10	FDA UDI	Class II	Active
Prevena™ Peel & Place™	Prevena Peel & Place Dressing- 13 cm	FDA UDI	Class II	Active
V.a.c.instill®	M6275413/5	FDA UDI	Class II	Unknown
Cellutome™	CT-SXT	FDA UDI	Class I	Unknown
Prevena Plus Duo™ Peel & Place™	PRE3321US	FDA UDI	Class II	Active

Related Companies

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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.