FDA: Cook recalls Central Venous Catheters and Pressure Monitoring Sets and Trays

Editor's Note

The Food and Drug Administration (FDA) on February 11 announced that Cook Medical (Bloomington, Indiana) initiated a recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays because of the potential for catheter tip fracture or separation.

The products were distributed between April 24, 2015, and October 23, 2015. No reports of illness or injury have been reported to date.

Single Lumen Central Venous Catheter Sets and Trays Single Lumen Pressure Monitoring Sets Femoral Artery Pressure Monitoring Catheter Sets and Trays Radial Artery Pressure Monitoring Catheter Sets and Trays [Posted 02/11/2016] AUDIENCE: Risk Manager ISSUE: During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation.