Home / Recalls / KCI USA, INC. / Z-2542-2020

Z-2542-2020 Class II Terminated

Recalled by KCI USA, INC. — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
July 15, 2020
Initiation Date
June 8, 2020
Termination Date
February 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,823 units

Product Description

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.

Reason for Recall

The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AZ, FL, IL, OH, MD, ND, NV, OK, SC, TN, TX, UT, VA, WA and Puerto Rico. The country of Australia, Austria, Canada, China, France, Germany, Japan, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.

Code Information

Products produced from 2007 to 2020 (with software versions up to 3.11) All serial numbers affected for the following model numbers: US: 340000 ACTIV.A.C., NORTH AMERICAN RTMGSM01/US ACTIVAC - RTM, NORTH AMERICAN Outside: 340001 ACTIV.A.C., UNITED KINGDOM 340003 ACTIV.A.C., AUSTRALIAN 340004 ACTIV.A.C., SPANISH 340005 ACTIV.A.C., GERMAN 340006 ACTIV.A.C., FRENCH 340007 ACTIV.A.C., ITALIAN 340008 ACTIV.A.C., DUTCH 340009 ACTIV.A.C., DANISH 340010 ACTIV.A.C., SWEDISH 340012 ACTIV.A.C., JAPAN 340013 ACTIV.A.C., CANADIAN 340015 ACTIV.A.C., TURKEY 340123 ACTIV.A.C., INDIA 340356 ACTIV.A.C., BRAZIL 415311 ACTIV.A.C., CZECH 415312 ACTIV.A.C., HUNGARIAN 415313 ACTIV.A.C., SLOVAKIAN 415314 ACTIV.A.C., CROATIAN 415315 ACTIV.A.C., POLAND 415316 ACTIV.A.C., SLOVENIA 415317 ACTIV.A.C., SOUTH AFRICA 416008 ACTIV.A.C., INDONESIA 416162 ACTIV.A.C., CHINA 416564 ACTIV.A.C., PHILIPPINES 416599 ACTIV.A.C., EUROPEAN UNION

Other recalls by KCI USA, INC.

  • Z-1175-2025 Class II — 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus D (January 17, 2025)
  • Z-1176-2025 Class II — 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V. (January 17, 2025)
  • Z-0507-2025 Class II — V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Nega (November 5, 2024)
  • Z-2171-2017 Class II — 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part (April 28, 2017)
  • Z-0600-2016 Class II — ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the appli (November 25, 2015)
  • Z-0933-2015 Class II — CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manu (November 19, 2014)
  • Z-0070-2015 Class II — V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and m (September 18, 2014)
  • Z-2717-2014 Class II — CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 (May 19, 2014)
  • Z-1135-2014 Class II — PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incis (January 30, 2014)
  • Z-1137-2014 Class II — PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Manage (January 30, 2014)