CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report
Lipofilter 3000, model Asp-can-2, labeled in part ***MicroAire recalled
MicroAire Surgical Instruments is recalling Lipofilter 3000, model Asp-can-2, labeled in part ***MicroAire, 1641, distributed nationwide in the US. The recall was initiated on 26 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1792-2012
- FDA event ID
- 61853
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2012
- FDA classified
- 8 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Apr 2012 | Recall initiated by company | |
| 8 Jun 2012 | Classified by FDA | +43 days |
| 20 Jun 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution including the states of CA, OH and NY.
Questions about this recall
Is Lipofilter 3000, model Asp-can-2, labeled in part ***MicroAire, 1641 recalled?
Yes. MicroAire Surgical Instruments recalled Lipofilter 3000, model Asp-can-2, labeled in part ***MicroAire, 1641 on 26 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-1792-2012.
Why was it recalled?
Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Which lots are affected?
Lot Number: 0312200152
Where was it sold?
US Nationwide Distribution including the states of CA, OH and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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