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KCI USA, INC. recalls ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute ex
Recalled January 13, 2016 · FDA recall Z-0600-2016 · KCI USA
Hazard
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters. · FDA Class II
Units
12,728 units
Sold at
Japan and Australia
Description
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Product
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
Manufacturer(s)
KCI USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →