Device product
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Z-1140-2014
Product summary
- Firm
- KCI USA, INC.
- Event
- Event 67454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,850 units total
- Official record key
device-enforcement:Z-1140-2014
Official wording
Reason: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information: Kit Lot # 2410919
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing