Device product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) 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-1136-2014
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-1136-2014
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 #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871
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