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U.S. Department of Health and Human Services

Class 2 Device Recall AR1000 Qoustic Qurette"

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 Class 2 Recall
AR1000 Qoustic Qurette"
see related information
Date Posted December 17, 2012
Recall Status1 Open
Recall Number Z-0534-2013
Recall Event ID 63808
Premarket Notification
510(K) Number
K062544 
Product Classification Instrument, Ultrasonic Surgical - Product Code LFL
Product Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.
Code Information 0001 and 0002
Recalling Firm/
Manufacturer
Arobella Medical, LLC
5929 Baker Rd Ste 470
Minnetonka, Minnesota 55345-4770
Manufacturer Reason
for Recall
This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Arobella Medical sent an " Urgent: Medical Device Recall" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.
Quantity in Commerce 99
Distribution Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = AROBELLA MEDICAL, LLC
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