Z-2542-2020Class II

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

Name: Z-2542-2020 ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 -
Creator: Kci USA, Inc.
Published: 2020-06-08
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2020-06-08 / Terminated

FDA source

KCI USA, INC. began a recall of 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... on 2020-06-08. FDA classified it as Class II and gives the reason as "The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2542-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-08
Posted: 2020-07-10
Terminated: 2023-02-07
Recalling firm: KCI USA, Inc.
Product: 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.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
FDA root cause: Under Investigation by firm
Action: For Customer Owned units, KCI plans to notify customers via customer letters delivered by common carriers or via email communication that the ACTIV.A.C." Therapy Unit may shut down without notification to the user. The customer letter notification or email communication will inform customers to coordinate the product software change. The recalling firm sent an URGENT - MEDICAL DEVICE RECALL letter to the affected customers on 06/08/2020. The completed Customer Response Form is to be returned to [email protected]
Quantity in commerce: 5,823 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-09

Product code OMP

K183543Class IIACTIV.A.C. Therapy UnitKci USA, Inc. / cleared 2019-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)