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U.S. Department of Health and Human Services

Class 2 Device Recall ASP1021LipoTower with Aspiration Pump and Tumescent Pump

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  Class 2 Device Recall ASP1021LipoTower with Aspiration Pump and Tumescent 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-2822-2015
Recall Event ID 72106
510(K)Number K113128  
Product Classification System, suction, lipoplasty - Product Code MUU
Product ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump.
Medical use.
Code Information Serial numbers 14101241, 4091238, 15011258, 15051279, 13101158, 15051275, 14021190, 12121111, 15051274, 14071221, 13081149, 13031123, 14021187, 14121254, 14081231, 13121173, 13111167, 13101164, 13121172, 14091234, 14111248, 14031196, 13061142, 15031264, 13121171, 13021116, 15051276, 13041131, 13101160, 14051210, 15041271, 14071222, 14051208, 15021260, 13111166, 13101163, 14111246, 13111168, 13101158, 14061212, 13081152, 13121177, 13061145, 15051280, 15061283, 14041200, 13021114, 14011184, 14031193, 13111165, 14011182, 14111249, 14101242, 14011181, 15041272, 13101156, 13041126, 14101240, 14021188, 12111108, 13061141, 12121112, 13061140, 13041128, 13081150, 14031195, 15051281, 14031197, 14081228, 14101243, 14031199, 14081232, 14071226, 13081148, 14111244, 14091238, 15051279, 13091154, 13121179, 14121252, 15041268, 14071225, 14071223, 15031266, 13031122, 13061144, 14021186, 14091233, 13101161, 14031194, 15041273, 13121170, 13021120, 13011113, 13121174, 14041201, 15021261, 14011183, 13061143, 13121175, 15021262, 15011259, 13101157, 14071227, 13091155, 13111169, 14121251, 14061211, 14071216, 14041207, 13041124, 14021189, 14011185, 14031198, 12101105, 14071224, 14041203, 14071220, 13051132, 14091239, 15041269, 14051209, 15021263, 15011257, 13081147, 13031121, 14101241, 15011258, 13041125, 13081151, 13101159, 13121176, 12121109, 14061213, 13121178

13101162, 14111245, 13061138, 14081229, 14021192, 14091237, 14121253, 13061139, 14121255, 15051278, 15051277, 14071217, 15011256, 13021118, 13071146, 13051135, 13051136, 13051137, 14071219, 14081230, 13041127, 12101106, 14061215, 12101107, 14061214, 15041267, 14041206, 14041202, 13041130, 13041129, 14021191, 13051133, 13051134, 14011180, 14091235, 14091236, 14111247, and 14111250.
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 168, ASP-1021 LipoTower with Aspiration Pump and Tumescent 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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