FDAFDA · Food and drugs·Recall number Z-1137-2014
PRE1055: Prevena 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.
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 2373868, 2397890, 2407867, 2410931, 2417878, 2417880
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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