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.
Enforcement
- Recall Number
- Z-0009-2013
- Event ID
- 63064
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Accuro Medical Product LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 10, 2012
- Initiation Date
- August 31, 2012
- Classification Date
- October 4, 2012
- Termination Date
- December 27, 2017
- Address
- 2854 Hitchcock Ave, N/A, Downers Grove, IL, 60515-4016, United States
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.
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.
part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
Worldwide distribution: USA (nationwide) and country of: Canada.
919 units