3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Ki...
FDA Device Recall #Z-1176-2025 — Class II — January 17, 2025
Recall Summary
| Recall Number | Z-1176-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 17, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | KCI USA, INC. |
| Location | San Antonio, TX |
| Product Type | Devices |
| 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.
Lot / 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 from KCI USA, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1175-2025 | Class II | 3M Prevena Plus 125 Therapy Unit and System Kit... | Jan 17, 2025 |
| Z-0507-2025 | Class II | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTD... | Nov 5, 2024 |
| Z-2542-2020 | Class II | ACTIV.A.C Therapy System; Model Numbers; US: 3... | Jun 8, 2020 |
| Z-2171-2017 | Class II | 1000 ml Canister (with Gel) for InfoV.A.C. and ... | Apr 28, 2017 |
| Z-0600-2016 | Class II | ActiV.A.C. 300ml Canister (with Gel) for ActiV.... | Nov 25, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.