Device 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.
Z-0600-2016
Product summary
- Firm
- KCI USA, INC.
- Event
- Event 72753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,728 units
- Official record key
device-enforcement:Z-0600-2016
Official wording
Reason: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
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
Derived failure modes
-
Unknown
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.