Recall Z-0600-2016
Kci USA, Inc. · initiated November 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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.
FDA-determined cause: Package design/selection
Action taken
Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees.
Details
- Recall number
- Z-0600-2016
- Initiated
- November 25, 2015
- Posted by FDA
- January 6, 2016
- Terminated
- November 17, 2016
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 12,728 units
- Distribution
- Japan and Australia
- Recalling firm
- Kci USA, Inc., San Antonio, TX