Reported Dec 21, 2016 · Terminated

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor…

Ellman International, Inc.

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: Ellman International, Inc. · 400 Karin Ln · Hicksville, NY · 11801-5352

Is this the product you have?

  • ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable
  • ContentsFive (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
Lot codes and dates
    • Lot Numbers 45572 (Box)
    • (Individual packages) 48543
    • 50382
    • 48543
    • 50704
    • 50858 Exp Date - 2018-02
Amount recalled
370 boxes (US - 159 boxes, OUS - 211 boxes)

Where it was sold

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.

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 Jun 18, 2018 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.