PRE1001US: Prevena Peel and Place System Kit — Class II medical device recall Z-1136-2014
Terminated recall by KCI USA, INC., reported 2014-03-12, distributed nationwide. Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to
| Recall number | Z-1136-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, INC., San Antonio, TX, United States |
| Recall initiated | 2014-01-30 |
| Classified | 2014-03-04 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2015-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 20,850 units |
| Lot numbers | 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871 |
Product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1136-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.