FDAFDA · Food and drugs·Recall number Z-0009-2013
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.
Published October 10, 2012 · Recall initiated: August 31, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accuro Medical Product LLC
- Distributor
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Lot
- part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.