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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

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.
Recall Number Z-1792-2012
Classification Class II
Code Info Lot Number: 0312200152
Product Distributed Qty 15 devices
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.

Event Detail

Event Id 61853
Product Type Devices
Status Ongoing
Recalling Firm MicroAire Surgical Instruments, LLC
City Charlottesville
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution including the states of CA, OH and NY.