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.
Reported: June 20, 2012 Initiated: April 26, 2012 #Z-1792-2012
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.
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.
Details
- Recalling Firm
- MicroAire Surgical Instruments, LLC
- Units Affected
- 15 devices
- Distribution
- US Nationwide Distribution including the states of CA, OH and NY.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by MicroAire Surgical Instruments, LLC. Units affected: 15 devices.
Why was this product recalled? ▼
Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2012. Severity: Moderate. Recall number: Z-1792-2012.
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