Cook Medical Issues Recall
Bloomington-based Cook Medical has issued a voluntary global recall of 360 lots of catheters and pressure monitoring sets and trays. The company says nearly 18,000 devices are being recalled due to catheter tip fracture and/or separation.
Cook says no reports of illness or injury have been associated with the recall to date. An internal inspection showed a catheter exhibiting the potential for fracture or separation, likely caused by "the technique used by the product assembler while tipping the catheter."
The company says the products in question were distributed globally between April 24 and October 23 of last year. They can be identified by the part number and lot number, which you can find by clicking here.
Cook says it notified customers and distributors in January, saying use of the affected products should be discontinued. The FDA and other global regulatory agencies have also been notified.
Cook says 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. They are intended for use in venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids.
Anyone with questions or needing to report adverse events can contact Cook Medical Customer Relations.