Minor Surgery Bipolar Cable 의 리콜

Recall

75351

Class 2

Z-0748-2017

2016-09-07

Terminated

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150114

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.

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 contacted by a Cynosure Customer Service Representative who will provide you with a RMA number for any cables that are being returned. Complete and return the response form via email to choy@cynosure.com. Cynosure will replace affected products at no charge upon receipt of the returned cables. Customers with questions should call 978-256-4200 or 800-886-2966. For questions regarding this recall call 516-267-6502.