PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision M...
FDA Device Recall #Z-1136-2014 — Class II — January 30, 2014
Recall Summary
| Recall Number | Z-1136-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 30, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | KCI USA, INC. |
| Location | San Antonio, TX |
| Product Type | Devices |
| Quantity | 20,850 units total |
Product Description
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
Distribution Pattern
USA Nationwide Distribution
Lot / Code Information
Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871
Other Recalls from KCI USA, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1176-2025 | Class II | 3M V.A.C. VIA Negative Pressure Wound Therapy S... | Jan 17, 2025 |
| Z-1175-2025 | Class II | 3M Prevena Plus 125 Therapy Unit and System Kit... | Jan 17, 2025 |
| Z-0507-2025 | Class II | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTD... | Nov 5, 2024 |
| Z-2542-2020 | Class II | ACTIV.A.C Therapy System; Model Numbers; US: 3... | Jun 8, 2020 |
| Z-2171-2017 | Class II | 1000 ml Canister (with Gel) for InfoV.A.C. and ... | Apr 28, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.