ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. ...
FDA Device Recall #Z-0600-2016 — Class II — November 25, 2015
Recall Summary
| Recall Number | Z-0600-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | KCI USA, INC. |
| Location | San Antonio, TX |
| Product Type | Devices |
| Quantity | 12,728 units |
Product Description
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
Reason for Recall
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Distribution Pattern
Japan and Australia
Lot / Code Information
Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.
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-2171-2017 | Class II | 1000 ml Canister (with Gel) for InfoV.A.C. and ... | Apr 28, 2017 |
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.