Device product
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.
Z-0009-2013
Product summary
- Event
- Event 63064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 919 units
- Official record key
device-enforcement:Z-0009-2013
Official wording
Reason: 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.
Code information: part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
Distribution pattern: Worldwide distribution: USA (nationwide) and country of: Canada.
Derived failure modes
-
Unknown
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.