Reported Aug 3, 2016 · Terminated

Endotine Transbleph 3.5 (CFD-080-0167)

MicroAire Surgical Instruments, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006

Is this the product you have?

  • Endotine Transbleph 3.5 (CFD-080-0167)
Lot codes and dates
    • Endotine Transbleph 3.5 (CFD-080-0167)
    • Lot # 285373
Amount recalled
29

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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 12, 2016 · Data as of Sep 19, 5:20 PM UTC

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