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Recall Observatory FDA recall evidence

Device product

PRE1001: Prevena Peel and Place System Kit 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-1135-2014

January 30, 2014

Class II

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-1135-2014

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 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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