U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Cook medical initiated a voluntary recall of specific lot numbers of the ventriclear ii ventricular drainage catheter set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
조치
Cook Medical issued letter via certified mail on 11/19/2015, for their voluntary recall of the VentriClear¿ II Ventricular Drainage Catheter Set due to being sterilized twice. The Distributor was instructed to forward the recall letter on to its customers, and quarantine any unused recalled devices, and return them to Cook Medical. Customers with questions may contact: Cook Medical Customer Relations 1-800-457-4500 or 1-812-339-2235. Monday
through Friday between 7:30a.m. and 5:00p.m. Eastern Daylight Time or email at
CustomerRelationsNA@cookmedical.com.