KCI USA, INC.: Device Recall
Recall #Z-1176-2025 · 01/17/2025
Recall Details
- Recall Number
- Z-1176-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- KCI USA, INC.
- Status
- Ongoing
- Date Initiated
- 01/17/2025
- Location
- San Antonio, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,169
Reason for Recall
Due to increase in complaints related to leak alarms
Product Description
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.
Other Recalls by KCI USA, INC.
- Class II: Risk 01/17/2025
- Class II: Risk 11/05/2024