Recall Z-2542-2020— KCI USA, INC.
Class II · Terminated
Class II FDA medical device recall by KCI USA, INC., initiated 2020-06-08, terminated 2023-02-07. It names one FDA 510(k) clearance: K183543. 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: The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy..
- Recalling firm
- KCI USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-08
- Terminated
- 2023-02-07
- Firm location
- San Antonio, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.