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Cook Medical recalls catheters subject to tip fracture, separation

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.

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.

Cook-MedicalDuring 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.

TAGS: Medical
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