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Recall Observatory FDA recall evidence

Device 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.

Z-0748-2017

September 07, 2016

Class II

Product summary

Firm
Ellman International, Inc.
Event
Event 75351
Status
Terminated
Classification
Class II
Quantity
370 boxes (US - 159 boxes, OUS - 211 boxes)
Official record key
device-enforcement:Z-0748-2017

Official wording

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.

Code information: Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeling