FDA-Device2016-08-03Class II

Endotine Transbleph 3.5 (CFD-080-0167)

MicroAire Surgical Instruments, LLC
Hazard

MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

Sold states
The product was distributed in the United States and Sweden
Affected count
29
Manufactured in
3590 Grand Forks Blvd, N/A, Charlottesville, VA, United States
Products
Endotine Transbleph 3.5 (CFD-080-0167)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2016

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