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.
Globally, 17,827 devices are subject to this recall. The recalled 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.
During an internal inspection, a catheter exhibited the potential for catheter 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. No reports of illness or injury have been associated with this issue to date.
Potential adverse events that may occur as a result of catheter tip fracture and/or separation 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. Examples of such complications include stroke, kidney injury, or damage to the intestines or limbs.
The single-lumen central venous catheters and pressure monitoring sets and trays in this recall were distributed globally between April 24, 2015, and October 23, 2015. Products can be identified by the part number and lot number that are provided on the outer package product label.
Shipments have been made globally to the following regions: Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, India, Israel, Italy, Jordan, Kuwait, Netherland, New Zealand, Panama, Puerto Rico, Spain, Switzerland, the UAE, the UK, and the USA.
Cook Medical has notified its customers and distributors by recall notification letters in January. All customers and distributors have been advised to quarantine and discontinue use of all affected units, and return the affected product to the company as soon as possible for credit.
Cook Medical has notified the US Food and Drug Administration and other global regulatory agencies of this action.