Z-1792-2012Class II

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

Name: Z-1792-2012 Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911...
Creator: MicroAire Surgical Instruments, LLC
Published: 2012-04-26
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2012-04-26 / Terminated / root cause: sterility

FDA source

MicroAire Surgical Instruments, LLC began a recall of Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister... on 2012-04-26. FDA classified it as Class II and gives the reason as "Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1792-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-26
Posted: 2012-06-09
Terminated: 2012-11-21
Recalling firm: MicroAire Surgical Instruments, LLC
Product: Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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.
Root cause tag: sterility
FDA root cause: Component change control
Action: 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 [email protected].
Quantity in commerce: 15 devices
Distribution: US Nationwide Distribution including the states of CA, OH and NY.
Product codes and lots: Lot Number: 0312200152

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1792-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1792-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-08

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)