Z-0748-2017 Class II Terminated
FDA device recall Z-0748-2017 was initiated by Ellman International, Inc. on September 7, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 18, 2018). Affected quantity: 370 boxes (US - 159 boxes, OUS - 211 boxes).
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- September 7, 2016
- Termination Date
- June 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 370 boxes (US - 159 boxes, OUS - 211 boxes)
Product Description
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.
Reason for Recall
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.
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.
Code Information
Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858 Exp Date - 2018-02