FDA Recall
Terminated
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.
Recall: Z-0600-2016
·
Initiated November 25, 2015
Recall
- Recall Number
- Z-0600-2016
- Event Number
- 72753
- Firm
- KCI USA, INC.
- FEI Number
- 3009897021
- Product Code
- OMP
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- November 25, 2015
- Posted
- January 6, 2016
- Terminated
- November 17, 2016
- Address
- 12930 W Interstate 10, San Antonio, TX, 78249-2248
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
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Action
Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees.
Distribution
Japan and Australia
Quantity
12,728 units