Cook Medical voluntarily recalled 360 lots of its single lumen central venous catheters and pressure monitoring sets and trays, according to an FDA news release. The recall included 17,287 devices, which are intended for use in venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids.
The company first noticed an issue during an internal inspection when it found a catheter tip could fracture or separate. The FDA said that Cook Medical found the product assembler’s technique while tipping the catheter likely contributed to the problem.
Although Cook Medical reported there were no illnesses or injuries associated with the issue, the FDA cited a few potential adverse events related to catheter tip fracture and/or separation, including complications such as stroke, kidney injury or damage to the intestine or limbs.
The catheters and monitoring sets and trays in this recall were distributed between April 24 and Oct. 23, 2015, in the U.S., Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, India, Israel, Italy, Jordan, Kuwait, the Netherlands, New Zealand, Panama, Puerto Rico, Spain, Switzerland, United Arab Emirates and United Kingdom.