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U.S. Department of Health and Human Services

Class 2 Device Recall ASP1020LipoTower with Aspiration Pump

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  Class 2 Device Recall ASP1020LipoTower with Aspiration Pump see related information
Date Initiated by Firm June 12, 2015
Date Posted September 30, 2015
Recall Status1 Terminated 3 on May 23, 2016
Recall Number Z-2821-2015
Recall Event ID 72106
510(K)Number K113128  
Product Classification System, suction, lipoplasty - Product Code MUU
Product ASP-1020 LipoTower with Aspiration Pump. Medical use.
Code Information Serial numbers 14031102, 15021105, and 14101103.
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information Contact Jordan Quiroz
434-975-8000
Manufacturer Reason
for Recall		 There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
FDA Determined
Cause 2		 Device Design
Action The firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.
Quantity in Commerce 3 LipoTower with Aspiration Pump
Distribution Nationwide Distribution.
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 = MUU and Original Applicant = MICROAIRE SURGICAL INSTRUMENTS, LLC
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