Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC,...
FDA Device Recall #Z-0009-2013 — Class II — August 31, 2012
Recall Summary
| Recall Number | Z-0009-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accuro Medical Product LLC |
| Location | Downers Grove, IL |
| Product Type | Devices |
| Quantity | 919 units |
Product Description
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Reason for Recall
Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Canada.
Lot / Code Information
part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
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.