Recall Z-0600-2016— KCI USA, INC.
Class II · Terminated
Class II FDA medical device recall by KCI USA, INC., initiated 2015-11-25, terminated 2016-11-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters..
- Recalling firm
- KCI USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-25
- Terminated
- 2016-11-17
- Firm location
- San Antonio, TX, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.