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www.fdanews.com/articles/175321-cook-recalls-central-venous-catheters-pressure-monitoring-sets-and-trays

Cook Recalls Central Venous Catheters, Pressure Monitoring Sets and Trays

February 11, 2016

Cook Medical has initiated a voluntary recall of 360 specific lots of single lumen central venous catheters and pressure monitoring sets and trays due to catheter tip fracture and/or separation, the company announced.

The global recall involves 17,827 devices distributed between April 24 and Oct. 23, 2015.

The products are specific versions and lot numbers of the single lumen central venous catheter sets and trays, single lumen pressure monitoring sets, femoral artery pressure monitoring catheter sets and trays and radial artery pressure monitoring catheter sets and trays.

These products are intended for use in venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids.

Cook notified its customers and distributors by recall notification letters in January. All customers and distributors should quarantine and discontinue use of all affected units and return the affected product to the company as soon as possible. — Jonathon Shacat