Events

Recall of Lipofilter 3000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MicroAire Surgical Instruments, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61853
  • Event Risk Class
    Class 2
  • Event Number
    Z-1792-2012
  • Event Initiated Date
    2012-04-26
  • Event Date Posted
    2012-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109241
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    Medical device was not manufactured under good manufacturing procedures and a user may be unable to sterilize the device according to procedures.
  • 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.

Device

Lipofilter 3000
  • Model / Serial
    Lot Number: 0312200152
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of CA, OH and NY.
  • 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.
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

MicroAire Surgical Instruments, LLC
  • Manufacturer Address
    MicroAire Surgical Instruments, LLC, 1641 Edlich Dr, Charlottesville VA 22911-5839
  • Manufacturer Parent Company (2017)
    Colson Associates Inc.
  • Source
    USFDA