Recall Z-0748-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Ellman International, Inc.
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.
| Date | Sep 7, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | Cynosure, Inc. dba Ellman distributed Urgent Medical Device Recall Notices dated September 6, 2016, and response forms to their customers via UPS overnight. Cynosure has identified an error in the Expiration Date on the label of the Minor Surgery Bipolar Cable pouch. The Expiration Date on the individual pouches that are provided in the 5 pack boxes do not match the Expiration Date on the box. The Expiration Date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. Actions To Be Taken - Return any cables subject to recall. You will be |
| Quantity | 370 boxes (US - 159 boxes, OUS - 211 boxes) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123366 | SURGITRON 4.0 DUAL RF S5-IEC Ellman International, Inc., Jul 12, 2013 |