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Terminated

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.

FDA Recall Z-1792-2012 · Posted 2012-06-09

Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeGCY
Date Initiated2012-04-26
Date Terminated2012-11-21
Product Quantity15 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.

Firm 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 [email protected].

Root Cause

Component change control

Distribution Pattern

US Nationwide Distribution including the states of CA, OH and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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