CLC2000 Positive Displacement Needlefree IV Connector March 2013
Voluntary Cease of U.S. Distribution
Frequently Asked Questions (FAQ’s)
In January 2013, ICU Medical announced it will voluntarily discontinue U.S. distribution of the CLC2000 positive displacement connector.
Is this a recall?
No. The decision to discontinue CLC2000 distribution in the U.S. is voluntary.
Why is CLC2000 distribution in the U.S. ending?
In August 2010 the FDA issued a Safety Communication that described a new requirement for nine manufacturers of positive displacement connectors to conduct post-market surveillance studies on these products. The requirement mandates that these manufacturers conduct extensive clinical surveillance study(s) to gather and report statistically relevant data from within multiple patient populations to answer specific questions regarding the products and their safety and efficacy. The FDA indicated that the companies have up to three years to complete the clinical studies to answer the questions, at which time the FDA will assess whether regulatory or other actions need to be taken. Due to the scope and overall cost of conducting such a study, ICU Medical opted to voluntarily cease US distribution rather than embark on such a lengthy and expensive project.
Why did ICU Medical opt to not conduct the clinical study?
ICU Medical launched the CLC2000 in the U.S. in 1998. Bringing new and innovative technologies to the market is at the core of what we do, and since that time we have launched several other connectors that have grown in popularity in the U.S. to the point that CLC2000 is a relatively small part of our U.S. business. Given the scope and overall cost of conducting a clinical study with the goal of continuing to distribute the product in the U.S. simply does not make sense financially.
Does ICU Medical have plans to cease distribution of CLC2000 outside of the U.S.?
No. ICU Medical understands that in most markets positive displacement connector technology is not under regulatory scrutiny and is in significant demand. Indeed, CLC2000 is a leading product in many markets and sales continue to be robust. ICU Medical intends to continue manufacturing and supporting this technology for the foreseeable future.
Are there any known safety concerns with the CLC2000?
No. CLC2000 has been in continuous use on millions of patients a year since 1998. There are no known clinical or safety concerns whatsoever.
ICU Medical corporate headquarters are located at 951 Calle Amanecer, San Clemente, CA 92673. For additional questions or concerns, please do not hesitate to contact our corporate offices at 800-824-7890 or +1 949 366 2183.
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