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) 4854350382485435070450858 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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