CLASS II Device recall · Reported 10 Oct 2012 · FDA Enforcement Report
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump recalled
Accuro Medical Product is recalling Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump, distributed nationwide in the US. The recall was initiated on 31 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0009-2013
- FDA event ID
- 63064
- Recalling firm
- Accuro Medical Product, Downers Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2012
- FDA classified
- 4 Oct 2012
- Reported
- 10 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2012 | Recall initiated by company | |
| 4 Oct 2012 | Classified by FDA | +34 days |
| 10 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) and country of: Canada.
Questions about this recall
Why was it 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.
Which lots are affected?
part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
Where was it sold?
Worldwide distribution: USA (nationwide) and country of: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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