ClearanceBrief
Recall Z-2821-2015 ยท MUU System, Suction, Lipoplasty

MicroAire Surgical Instruments, LLC

ASP-1020 LipoTower with Aspiration Pump. Medical use.

DateSep 30, 2015 (initiated Jun 12, 2015)
StatusTerminated
ReasonThere is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Root causeDevice Design
ActionThe firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.
Quantity3 LipoTower with Aspiration Pump
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K113128MICROAIRE SURGICAL INSTRUMENTS LLC
Microaire Surgical Instruments, LLC, Aug 17, 2012