Recall Z-1176-2025 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, INC.
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
| Date | Feb 14, 2025 (initiated Jan 17, 2025) |
| Status | Open, Classified |
| Reason | Due to increase in complaints related to leak alarms |
| Root cause | Device Design |
| Action | On 01/17/2025, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Letter via US Postal to customers informing them that Solventum has identified that devices distributed between March 11, 2024 and November 18th, 2024 were released with a leak alarm threshold lower than the design specification. This results in the therapy unit prematurely alarming although there is no leak within the system and potentially continuing to alarm during therapy although there is no visible leak. Customers are instructed to: 1.Screen their facility or other storage locations for the impacted products and lot numbe |
| Quantity | 2,169 |
| 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 Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062227 | V.A.C. THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.), Oct 4, 2006 |