KCI USA, INC.: Medical Device Recall in 2016 - (Recall #: Z-0600-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: January 13, 2016

Recall Number: Z-0600-2016

Event ID: 72753

Reason for Recall:

There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

Status: Terminated

Product Quantity: 12,728 units

Code Information:

Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.

Distribution Pattern:

Japan and Australia

Voluntary or Mandated:

Voluntary: Firm initiated