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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85734

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
KCI USA, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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-2542-2020
Recall number
Z-2542-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
KCI USA, INC.
Quantity
5,823 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

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.