Cook Medical (Bloomington, IN) has initiated a voluntary recall of 360 specific lots of single-lumen central venous catheters and pressure monitoring sets and trays because of possible catheter tip fracture or separation.
During an internal inspection at Cook Medical, notes an FDA press release published yesterday, a catheter exhibited the potential for tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. Potential adverse events that may occur as a result include loss of device function, the need for medical intervention to retrieve a separated segment and complications resulting from a separated tip occluding blood flow to end organs, adds FDA, which cites stroke, kidney injury, and damage to the intestines or limbs as possible consequences.
Cook Medical initiated a global recall of 17,827 affected devices on Jan. 6, 2016.
The specific recalled products and lot numbers are published on the FDA website.