FDA Medical devices recall ·
3M V.A.C. VIA Negative Pressure Wound Therapy System recall
- Recall number
- Z-1176-2025
- Date
- (initiated January 17, 2025)
- Company / brand
- Kci USA, Inc.
12930 W Interstate 10, San Antonio, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,169
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to increase in complaints related to leak alarms
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1176-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.