Recall Z-1792-2012 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
MicroAire Surgical Instruments, LLC
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.
| Date | Jun 9, 2012 (initiated Apr 26, 2012) |
| Status | Terminated |
| Reason | Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures. |
| 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 toddm@microaire.com. |
| Quantity | 15 devices |
| Distribution | US Nationwide Distribution including the states of CA, OH and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.