ICU Medical, Inc. Discontinues U.S. Distribution of Needlefree IV Connector on FDA Safety Concerns
January 28, 2013 at 08:54 am EST
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ICU Medical, Inc. announced that it will 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.
ICU Medical, Inc. develops, manufactures, and sells medical products used in infusion therapy, vascular access, and vital care applications. Its product portfolio includes ambulatory, syringe, and large volume IV pumps and safety software; dedicated and non-dedicated IV sets, needle free IV connectors, peripheral IV catheters, and sterile IV solutions; closed system transfer devices and pharmacy compounding systems; as well as a range of respiratory, anesthesia, patient monitoring, and temperature management products. Its Infusion Therapy products include Clave needlefree products, Neutron, and Tego. Its oncology products include ChemoLock Closed System Transfer Devices (CSTD) and Deltec GRIPPER non-coring needles for portal access. Its vascular access products include Safe-T Wing venipuncture and blood collection devices; Port-A-Cath implantable port, and Portex arterial blood sampling syringes. Its Tracheostomy product include Portex BLUselect PVC tracheostomy tubes.