FDAFDA · Food and drugs·Recall number Z-1135-2014
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.
Published March 12, 2014 · Recall initiated: January 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- KCI USA, INC.
- Distributor
- USA Nationwide Distribution
- Lot
- Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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