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

Recalled July 15, 2020 · FDA recall Z-2542-2020 · KCI USA

Hazard

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

Units

5,823 units

Sold at

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.

Description

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

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.

Manufacturer(s)

KCI USA, INC.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →