FDA recalls Cook Medical catheter components

March 3, 2011 by MassDevice staff

The Food & Drug Administration issues a Class I recall for central venous catheter instrumentation manufactured by Cook Medical.


The Food & Drug Administration issued a Class I recall for venous catheter components manufactured by Cook Medical.

The devices are used by doctors to monitor patients' venous pressure, conduct blood sampling and for the administration of drugs and fluids, according to the company.

The FDA classified the recall action as Class I, meaning the federal agency believes that use of the equipment could cause serious injury or death.

Cook Medical sent a recall letter to its customers Oct. 4, 2010, and the FDA posted recall notices for the catheter components on its website Feb. 23. The recall refers specifically to Cook's single, double, triple and five-lumen central venous catheter trays; and single and double lumen peripheral inserted central venous catheter (PICC) trays distributed between Jan. 1, 2009 and Sept. 30, 2010.

The kits and trays contain 0.9 percent Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes distributed by Excelsior Medical that are subject to a Class I recall. Leaks discovered during a routine syringe test could cause the devices to become desterilized.