# FDA recall Z-2542-2020

> **KCI USA, INC.** · Class II · device recall initiated 2020-06-08.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-2542-2020
- **Recalling firm:** KCI USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-08
- **Report date:** 2020-07-15
- **Termination date:** 2023-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Antonio, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2542-2020

## Citation

> AI Analytics. FDA recall Z-2542-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2542-2020. Source: US FDA. Licensed CC0.

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