Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2822-2015Class II

ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use

MicroAire Surgical Instruments, LLC / initiated 2015-06-12 / Terminated / root cause: design

MicroAire Surgical Instruments, LLC began a recall of ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use on . FDA classified it as Class II and gives the reason as "There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2822-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MicroAire Surgical Instruments, LLC
Product
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
Product code
MUU System, Suction, Lipoplasty
Reason for recall
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Root cause tag
design
FDA root 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
168, ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
Distribution
Nationwide Distribution.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2822-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2821-2015Class IITerminatedVoluntary: Firm initiated
Z-2822-2015Class IITerminatedVoluntary: Firm initiated