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
Product summary
- 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
Mislabeling