Recall Z-0748-2017— Ellman International, Inc.

Name: FDA recall Z-0748-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-07

Class II · Terminated

Class II FDA medical device recall by Ellman International, Inc., initiated 2016-09-07, terminated 2018-06-18. It names one FDA 510(k) clearance: K123366. Product: 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.. Reason: 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..

Recalling firm: Ellman International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Terminated: 2018-06-18
Firm location: Hicksville, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K123366 — SURGITRON 4.0 DUAL RF S5-IECEllman International, Inc.·cleared 2013-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.