Recall Z-1792-2012
MicroAire Surgical Instruments, LLC · initiated April 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number: 0312200152
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.
FDA-determined cause: Component change control
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.
Details
- Recall number
- Z-1792-2012
- Initiated
- April 26, 2012
- Posted by FDA
- June 9, 2012
- Terminated
- November 21, 2012
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Quantity
- 15 devices
- Distribution
- US Nationwide Distribution including the states of CA, OH and NY.
- Recalling firm
- MicroAire Surgical Instruments, LLC, Charlottesville, VA