KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off
KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the cessation of a therapeutic procedure (negative pressure wound therapy) without warning, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
KCI USA, INC. is recalling the ACTIV.A.C Therapy System, an integrated wound management device used in acute, extended, and home care settings. The recall involves 5,823 units produced between 2007 and 2020 with software versions up to 3.11. The devices are distributed worldwide, including in the United States and numerous international markets.
The recall is being conducted because the device may power off without notification to the user. This unexpected shutdown results in a stoppage of negative pressure wound therapy, which is intended to promote wound healing by preparing the wound bed, reducing edema, and removing exudate.
Healthcare providers and patients using the ACTIV.A.C Therapy System should contact KCI USA for further instructions on how to proceed with the recall and ensure patient safety.
The recalled product
- 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 environm
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- Affected units
- 5,823
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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.
Distribution
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