Reported Oct 10, 2012 · Terminated
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave,…
Accuro Medical Product LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuro Medical Product LLC · 2854 Hitchcock Ave · Downers Grove, IL · 60515-4016
Is this the product you have?
- 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.
- Lot codes and dates
part number 84635400182serial numbers E000146 through E002039(all serial numbers)
- Amount recalled
- 919 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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