Medical device recalls Moderate risk

KCI USA, INC. recalls 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…

Recall date
January 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1176-2025
FDA classification
Class II
Brand / firm
KCI USA, INC.
Sold / distributed
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…

Why it was recalled

Due to increase in complaints related to leak alarms

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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