Recall Z-0507-2025 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, INC.
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
| Date | Nov 22, 2024 (initiated Nov 5, 2024) |
| Status | Open, Classified |
| Reason | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
| Root cause | Use error |
| Action | On 11/05/2024, the firm sent an "URGENT - MEDICAL DEVICE CORRECTION" Letter to customers informing them that due to a potentially broken occlusion sensor that the Veraflo instillation therapy units may encounter a System Error 007 alarm during boot up which may delay therapy. Customer are instructed to: 1. Locate all serial numbers and Therapy Unit Software version of V.A.C. Ulta Therapy Units. 2. Perform the steps outlined in the attached test procedure for the occlusion detection sensor 3. Record the test results on the provided Field Notice Receipt and Customer Response Form. Complete all |
| Quantity | 83,721 devices |
| Distribution | Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System Kci USA, Inc. (Kinetic Concepts, Inc.), Jan 26, 2017 |