1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5...
FDA Device Recall #Z-2171-2017 — Class II — April 28, 2017
Recall Summary
| Recall Number | Z-2171-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 28, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | KCI USA, INC. |
| Location | San Antonio, TX |
| Product Type | Devices |
| Quantity | 5,385 cases |
Product Description
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are 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. All exudates and infectious materials are collected in the canister
Reason for Recall
Potential sterile barrier breach
Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia
Lot / Code Information
51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, 51022719
Other Recalls from KCI USA, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1175-2025 | Class II | 3M Prevena Plus 125 Therapy Unit and System Kit... | Jan 17, 2025 |
| Z-1176-2025 | Class II | 3M V.A.C. VIA Negative Pressure Wound Therapy S... | 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-0600-2016 | Class II | ActiV.A.C. 300ml Canister (with Gel) for ActiV.... | Nov 25, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.