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KCI USA, INC. recalls PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is int
Recalled March 12, 2014 · FDA recall Z-1136-2014 · KCI USA
Hazard
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 · FDA Class II
Units
20,850 units total
Sold at
USA Nationwide Distribution
Description
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
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.
Manufacturer(s)
KCI USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →