Medical Device Recall: 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 Ther
KCI USA, INC. · November 5, 2024
Reason for Recall
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
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.
Distribution
Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania, Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand, South Africa, Vietnam, and Denmark
States Affected
NATIONWIDE
Quantity Affected
83,721 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0507-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.