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U.S. Department of Health and Human Services

Class 2 Device Recall Lipofilter 3000

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  Class 2 Device Recall Lipofilter 3000 see related information
Date Initiated by Firm April 26, 2012
Date Posted June 09, 2012
Recall Status1 Terminated 3 on November 21, 2012
Recall Number Z-1792-2012
Recall Event ID 61853
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
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.
Code Information Lot Number: 0312200152
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
1641 Edlich Dr
Charlottesville VA 22911-5839
For Additional Information Contact Todd Moore
434-975-8000
Manufacturer 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 2		 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 in Commerce 15 devices
Distribution US Nationwide Distribution including the states of CA, OH and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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