Recall Z-0009-2013— Accuro Medical Product LLC

Name: FDA recall Z-0009-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-31

Class II · Terminated

Class II FDA medical device recall by Accuro Medical Product LLC, initiated 2012-08-31, terminated 2017-12-27. It names one FDA 510(k) clearance: K100823. 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..

Recalling firm: Accuro Medical Product LLC
Classification: Class II
Status: Terminated
Initiated: 2012-08-31
Terminated: 2017-12-27
Firm location: Downers Grove, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K100823 — WOUND PRO APEXAccuro Medical Products, LLC·cleared 2011-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.