PRE2055: Prevena Customizable 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.
Reported: March 12, 2014 Initiated: January 30, 2014 #Z-1140-2014
Product Description
PRE2055: Prevena Customizable 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.
Reason for Recall
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
Details
- Recalling Firm
- KCI USA, INC.
- Units Affected
- 20,850 units total
- Distribution
- USA Nationwide Distribution
- Location
- San Antonio, TX
Frequently Asked Questions
What product was recalled? ▼
PRE2055: Prevena Customizable 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.. Recalled by KCI USA, INC.. Units affected: 20,850 units total.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2014. Severity: Moderate. Recall number: Z-1140-2014.
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