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Class 2 Device Recall Lipofilter 3000 |
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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
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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
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For Additional Information Contact |
Todd Moore 434-975-8000
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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.
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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
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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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