Ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable recalled over labeling errors

Recall date

September 7, 2016

Source

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

Official notice title

Ellman International, Inc. recalls ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor S…

Recall number

Z-0748-2017

FDA classification

Class II

Brand / firm

Ellman International, Inc.

Sold / distributed

Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.

Why it was recalled

Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.

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

What was recalled

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.