KCI USA, INC.: Device Recall

Recall #Z-0507-2025 · 11/05/2024

Class II: Risk

Recall Details

Recall Number
Z-0507-2025
Classification
Class II
Product Type
Device
Recalling Firm
KCI USA, INC.
Status
Ongoing
Date Initiated
11/05/2024
Location
San Antonio, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
83,721 devices

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 Pattern

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

Other Recalls by KCI USA, INC.

View all recalls by KCI USA, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.