Recall Z-1176-2025— KCI USA, INC.

Name: FDA recall Z-1176-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-17

Class II · Ongoing

Class II FDA medical device recall by KCI USA, INC., initiated 2025-01-17. It names one FDA 510(k) clearance: K062227. 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. Reason: Due to increase in complaints related to leak alarms.

Recalling firm: KCI USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-17
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K062227 — V.A.C. THERAPY SYSTEMKci USA, Inc. (Kinetic Concepts, Inc.)·cleared 2006-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.