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.
This recall has been terminated (originally issued June 8, 2020).
- Company
- Kci Usa, Inc.
- Recall Initiated
- June 8, 2020
- Terminated
- February 7, 2023
- Recall Number
- Z-2542-2020
- Quantity
- 5,823 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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 kci3mfieldactionresponse@mmm.com