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. |
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