Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Pro

FDA device recall Z-1792-2012 · posted 2012-06-09 · Terminated

Recall details

Recalling firm

MicroAire Surgical Instruments, LLC

Reason for recall

Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.

Action taken

MicroAire Surgical Instrument sent a Device Removal Notice letter dated April 26, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to recover the affected product from inventory and quarantine. Customers were instructed to contact MicroAire Customer Service Department at 800-975-8000 or 434-975-8000 to arrange for return and replacement of the affected product. For questions call 434-975-8336 or email toddm@microaire.com.

Root cause

Component change control

Status

Terminated

Product code

GCY

Quantity affected

15 devices

Distribution

US Nationwide Distribution including the states of CA, OH and NY.

Date initiated

2012-04-26

Date posted

2012-06-09

Date terminated

2012-11-21

Location

Charlottesville, VA