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U.S. Department of Health and Human Services

Class 2 Device Recall Negative Pressure Wound Therapy Powered Suction Pump

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  Class 2 Device Recall Negative Pressure Wound Therapy Powered Suction Pump see related information
Date Initiated by Firm August 31, 2012
Date Posted October 04, 2012
Recall Status1 Terminated 3 on December 27, 2017
Recall Number Z-0009-2013
Recall Event ID 63064
510(K)Number K100823  
Product Classification Wound Pro Apex Negative Pressure Wound Therapy - Product Code OMP
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.
Code Information part number 84635400182, serial numbers E000146 through E002039, (all serial numbers) 
Recalling Firm/
Manufacturer		 Accuro Medical Product LLC
2854 Hitchcock Ave
Downers Grove IL 60515-4016
For Additional Information Contact Mr. Timothy Costa
630-670-4102
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.
Quantity in Commerce 919 units
Distribution Worldwide distribution: USA (nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OMP and Original Applicant = ACCURO MEDICAL PRODUCTS LLC
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