FDA Device recall Z-1135-2014
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of s…
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of s… by Kci Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1135-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-30 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kci Usa |
| Distribution | US |
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
Identifiers
| code_info | Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2014%22
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