Class 2 Device Recall ASP1020LipoTower with Aspiration Pump

• Date Initiated by Firm: June 12, 2015
• Date Posted: September 30, 2015
• Recall Status: Terminated 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.
• FEI Number: 2020601
• 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: 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