Recall Z-2822-2015— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-2822-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2015-06-12, terminated 2016-05-23. It names one FDA 510(k) clearance: K113128. Product: ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.. Reason: There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Terminated: 2016-05-23
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K113128 — MICROAIRE SURGICAL INSTRUMENTS LLCMicroaire Surgical Instruments, LLC·cleared 2012-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.

Data sourced from openFDA. This site is unofficial and independent of the FDA.