KCI USA, INC.

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
28
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1175-2025Class II3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20January 17, 2025
Z-1176-2025Class II3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit January 17, 2025
Z-0507-2025Class IIV.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound November 5, 2024
Z-2542-2020Class IIACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008June 8, 2020
Z-2171-2017Class II1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). April 28, 2017
Z-0600-2016Class IIActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. TheNovember 25, 2015
Z-0933-2015Class IICelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USNovember 19, 2014
Z-0070-2015Class IIV.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infecSeptember 18, 2014
Z-2717-2014Class IICelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50May 19, 2014
Z-1137-2014Class IIPRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intenJanuary 30, 2014
Z-1142-2014Class IIPRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision MaJanuary 30, 2014
Z-1140-2014Class IIPRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management SysJanuary 30, 2014
Z-1141-2014Class IIPRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The PrevJanuary 30, 2014
Z-1139-2014Class IIPRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena IncisionJanuary 30, 2014
Z-1136-2014Class IIPRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision ManaJanuary 30, 2014
Z-1135-2014Class IIPRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management SysteJanuary 30, 2014
Z-1138-2014Class IIPRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management SysJanuary 30, 2014
Z-2466-2012Class IIBariAir Therapy System The BariAir Therapy System is a risk management treatment system designed September 17, 2012
Z-0409-2013Class IIRotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complicaJune 27, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)May 23, 2024
K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemJuly 8, 2020
K200390V.A.C. DERMATAC DrapeMay 18, 2020
K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)November 22, 2019
DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsApril 19, 2019
K181505V.A.C. DERMATAC DrapeMarch 28, 2019
K183543ACTIV.A.C. Therapy UnitMarch 20, 2019
K181507PREVENA RESTOR(TM) Incision Management SystemFebruary 15, 2019
K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemJune 1, 2018
K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemMarch 9, 2018
K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure WoundMarch 2, 2018
K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemDecember 9, 2016
K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place DrFebruary 29, 2016
K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System wiNovember 6, 2015
K133276V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSNovember 19, 2013
K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEMNovember 15, 2013
K123507KCI NPWT GAUZE DRESSINGApril 4, 2013
K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAMay 31, 2012
K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNITJuly 21, 2011
K100821PREVENA INCISION MANAGEMENT SYSTEMJune 11, 2010