FDA: Global Recall of Cook Medical Central Venous Catheters and Pressure Monitoring Sets, Trays
Cook Medical has issued a voluntary global recall of 360 specific lots of central venous catheters and pressure monitoring sets and trays. The recall was initiated January 6, 2016, after an internal inspection revealed that a catheter exhibited the potential for tip fracture and/or separation, the company reported.
The FDA posted the recall to its website today.
At the time of recall, customers and distributors were sent notification letters instructing them to “quarantine and discontinue” all affected units and return them to the company for credit.
The recall applies to 17,827 devices distributed globally between April 24, 2015, and October 23, 2015. These include: single lumen central venous catheter sets and trays, single lumen pressure monitoring sets, femoral artery pressuring monitoring catheter sets and trays, and radial artery pressure monitoring catheter sets and trays.
There have been no reports of illness or injury associated with this issue to date, although the company acknowledges the potential for adverse events as a result of catheter tip fracture and/or separation. Possible events 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” that could lead to stroke, kidney injury, or injury to the intestines or limbs.
The company said their investigation into the matter revealed that the technique used by the product assembler while “tipping the catheter” likely contributed to the problem.
Specific part numbers and lot numbers affected by this recall can be found here. The FDA is encouraging healthcare professionals and patients to report adverse events or side effects related to the use of these products to MedWatch.
Food and Drug Administration. Central venous catheters and pressure monitoring sets and trays by Cook Medical: recall - catheter tip fracture and/or separation. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm485910.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
Published on: February 11, 2016. Accessed on: February 11, 2016.