Recall Z-0507-2025— KCI USA, INC.
Class II · Ongoing
Class II FDA medical device recall by KCI USA, INC., initiated 2024-11-05. It names one FDA 510(k) clearance: K162790. 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.. Reason: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors..
- Recalling firm
- KCI USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-05
- 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
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.
Reason for recall
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.