Home / Recalls / KCI USA, INC. / Z-1176-2025

Z-1176-2025 Class II Ongoing

Recalled by KCI USA, INC. — San Antonio, TX

FDA device recall Z-1176-2025 was initiated by KCI USA, INC. on January 17, 2025 and is designated Class II. Reason for recall: Due to increase in complaints related to leak alarms The recall status is ongoing. Affected quantity: 2,169.

Recall Details

Product Type
Devices
Report Date
February 26, 2025
Initiation Date
January 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,169

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

Reason for Recall

Due to increase in complaints related to leak alarms

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.

Code Information

VIAKIT077D01/US V.A.C. VIA 7 DAY KIT UDI-DI code: 00849554002388 Assembly Item Number: VIAKIT077D01/USV003 Lot Numbers: C17525V003 C17557V003 VIAKIT07S05/AU V.A.C. VIA STARTER KIT 5-PACK UDI-DI code: 00849554002401 Assembly Item Number: VIAKIT07S05/AUV003 Lot Number: C16937V003 VIAKIT077D01/GB V.A.C. VIA 7 DAY KIT, SINGLE SHIPPER UDI-DI code: 00849554002364 Assembly Item Number: VIAKIT077D01/GBV003 Lot Numbers: C16936V003 C17027V003

Other recalls by KCI USA, INC.

  • Z-1175-2025 Class II — 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus D (January 17, 2025)
  • Z-0507-2025 Class II — V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Nega (November 5, 2024)
  • Z-2542-2020 Class II — ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN (June 8, 2020)
  • Z-2171-2017 Class II — 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part (April 28, 2017)
  • Z-0600-2016 Class II — ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the appli (November 25, 2015)
  • Z-0933-2015 Class II — CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manu (November 19, 2014)
  • Z-0070-2015 Class II — V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and m (September 18, 2014)
  • Z-2717-2014 Class II — CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 (May 19, 2014)
  • Z-1136-2014 Class II — PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The P (January 30, 2014)
  • Z-1140-2014 Class II — PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Inc (January 30, 2014)

FDA data resources