V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.
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: This is a Class II medical device recall affecting over 83,000 units. The V.A.C. Ulta is a risk-of-harm product used for critical wound therapy, and broken occlusion sensors preventing therapy initiation pose potential for serious adverse health consequences. No illnesses or injuries have been reported.
Plain-English summary
KCI USA, INC. is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units. The V.A.C. Ulta is an integrated wound management system that provides negative pressure wound therapy with an instillation option. The recall involves multiple model variants with specific serial number ranges.
The recall was initiated due to potential system error alarms and the inability to initiate therapy as a result of broken occlusion sensors in affected units. When occlusion sensors are broken, the device may fail to initiate the therapy it is designed to deliver.
The affected units have been distributed worldwide. Distribution includes all U.S. states and territories, as well as international distribution to countries including Australia, Canada, Germany, Italy, Japan, Mexico, the United Kingdom, and others.
The recalled product
- Product
- V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Therapy
- Hazard
- system-error
- sensor-failure
- therapy-failure
Distribution
Distributed nationwide across the United States.
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