Z-0009-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- August 31, 2012
- Termination Date
- December 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)