Device 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.
Z-1792-2012
Product summary
- Event
- Event 61853
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 devices
- Official record key
device-enforcement:Z-1792-2012
Official wording
Reason: Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Code information: Lot Number: 0312200152
Distribution pattern: US Nationwide Distribution including the states of CA, OH and NY.
Derived failure modes
-
Unknown
Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.