SAN CLEMENTE, Calif., Jan.28, 2013 – ICU Medical, Inc. (NASDAQ:ICUI) today announced it will voluntarily discontinue U.S. distribution of the CLC2000® Positive Displacement Needlefree Connector effective April 30, 2013 due to FDA concerns over the safety of positive displacement needlefree connectors and sharply decreasing U.S. sales volumes caused by customers switching to the company’s newer, clinically superior needlefree connector technologies. The CLC2000 will continue to be available for purchase in markets outside the United States.
Launched over a decade and a half ago, CLC2000 was the first positive displacement needlefree connector on the market and the first connector ever developed specifically to help maintain catheter patency. Today, this positive displacement technology has largely been replaced in the U.S. by clinicians choosing the neutral displacement features of the MicroClave® Clear and, more recently, the anti-reflux technology of the Neutron™ Catheter Patency Device, the first and only FDA-cleared device shown to significantly reduce all types of reflux into a catheter and be cleared for use on all patients, including pediatric and immunocompromised patients.
In addition, FDA concerns regarding the safety of positive displacement needlefree connectors prompted the agency to require manufacturers to perform extensive post-market surveillance of these devices.1Given the decreasing demand for the CLC2000 and the ready availability of its clinically superior needlefree technology options, ICU Medical has chosen to remove the CLC2000 from the U.S. market rather than invest in an expensive study of an outdated technology.
“The MicroClave Clear Neutral Displacement Needlefree Connector and the Neutron Catheter Patency Device are available in sufficient quantities to begin transition of all existing United States CLC2000 customers immediately,” explained ICU Medical Vice President of Sales Richard Costello. “ICU Medical Product Sales Representatives will work with clinical and purchasing personnel in each facility to discuss the different options and determine which of the alternative products will be considered an appropriate replacement for the CLC2000.”
For customer questions, support, or to be put in contact with a local ICU Medical Product Sales Representative to discuss replacement options, please contact ICU Medical customer service directly at (866) 829-9025 Monday through Friday between 8:oo a.m. and 8:00 p.m. EST, or via e-mail at email@example.com.
1 FDA Medical Device Safety Alert, July 28, 2010: Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors (http://www.fda.gov/Medical Devices/Safety/AlertsandNotices/ucm220459.htm).