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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 63064
Product Type Devices
Status Ongoing
Recalling Firm Accuro Medical Product LLC
City Downers Grove
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. part number 84635400182, serial numbers E000146 through E002039, (all serial numbers) Class II 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. 919 units Z-0009-2013