Recall Z-1792-2012— MicroAire Surgical Instruments, LLC
Class II · Terminated
Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2012-04-26, terminated 2012-11-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures..
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-26
- Terminated
- 2012-11-21
- Firm location
- Charlottesville, VA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.