Recall Z-1135-2014— KCI USA, INC.
Class II · Terminated
Class II FDA medical device recall by KCI USA, INC., initiated 2014-01-30, terminated 2015-04-06. It names 2 FDA 510(k) clearances: K123878, K100821. 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.. 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.
- Recalling firm
- KCI USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-30
- Terminated
- 2015-04-06
- Firm location
- San Antonio, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
- K100821 — PREVENA INCISION MANAGEMENT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.