Reported Jul 15, 2020 · Terminated

ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage:…

Kci USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: KCI USA, INC. · 12930 W Interstate 10 · San Antonio, TX · 78249-2248

ACTIV.A.C Therapy System; Model Numbers
US340000 ACTIV.A.C., NORTH AMERICAN
UDI (01)00878237008188 - Product Usageis 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

Lot codes and dates: 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
Amount recalled: 5,823 units

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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10 in total.