Endotine Transbleph 3 recalled over labeling errors

Recall date

May 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MicroAire Surgical Instruments, LLC recalls Endotine Transbleph 3.5 (CFD-080-0167)

Recall number

Z-2294-2016

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

The product was distributed in the United States and Sweden

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endotine Transbleph 3.5 (CFD-080-0167)