FDA Device recall Z-0009-2013
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump
- FDA Device
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump by Accuro Medical Product, citing 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 displa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-31 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Accuro Medical Product |
| Distribution | US |
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.
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.
Identifiers
| code_info | part number 84635400182, serial numbers E000146 through E002039, (all serial numbers) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2013%22
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