Kci USA, Inc.
Kci USA, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2024, with 19 FDA device recalls on record.
Top product codes for Kci USA, Inc.
FDA recalls by Kci USA, Inc.
10 most recent of 19- 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.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
- Z-1175-2025 — 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
- 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 integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
- Z-2542-2020 — ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
- Z-2171-2017 — 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister
- Z-0600-2016 — ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
- Z-0933-2015 — CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
- Z-0070-2015 — V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
- Z-2717-2014 — CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
- Z-1141-2014 — PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Kci USA, Inc.
- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System
- K200390 — V.A.C. DERMATAC Drape
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
- K181505 — V.A.C. DERMATAC Drape
- K183543 — ACTIV.A.C. Therapy Unit
- K181507 — PREVENA RESTOR(TM) Incision Management System
- K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
- K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
- K173447 — 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
- K160487 — V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
- K153199 — 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
- K150006 — Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
- K133276 — V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
- K132741 — V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K123507 — KCI NPWT GAUZE DRESSING
- K120033 — ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
- K111280 — V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
- K100821 — PREVENA INCISION MANAGEMENT SYSTEM
- K091585 — VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
- K090489 — ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
- K083357 — OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
- K063692 — V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
- K063740 — V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
- K063590 — V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
- K063426 — V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
- K053627 — MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.