Recall record at a glance
| Official record | Z-2542-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | KCI USA, Inc. |
| Report date | Jul 15, 2020 |
| Recall initiation date | Jun 8, 2020 |
| Quantity | 5,823 units |
| Location | San Antonio, TX, United States |
Official product description
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.
Why the product was recalled
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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