Cook Medical is recalling 360 lots of its single lumen central venous catheters, pressure monitoring sets and trays due to issues with catheter tip fracture and separation.
A total of 17,872 devices are subject to the recall, according to Cook Medical, who said it began notifying customers and distributors of the issue in January and that it has contacted the FDA and other regulatory bodies over the issue.
The problem was discovered during an internal inspection, in which a catheter â€œexhibited the potential for catheter tip fracture and/or separation,â€ according to an FDA press release. Cook Medical said they investigated further and found the technique used by the assembler to attach the tip was likely at fault.
Cook Medical said there have been no reports of injury or illness associated with the issue, though potential adverse events could occur due to tip fracture or separation that would require medical interventions to retrieve the fractured or separated tips.
Such an event could result in occluded blood flow to end organs, with complications including stroke, kidney injury or damage to the intestines or limbs, the company said.
The devices were distributed internationally between April 2013 and October 2015.
The recall affects multiple part, product and lot numbers. Included in the recall are Cookâ€™s femoral artery pressure monitoring catheter tray, femoral artery pressure monitoring catheter set, radial artery pressure monitoring catheter tray, radial artery pressure monitoring catheter set, single lumen central venous catheter set, single lumen central venous catheter tray and single lumen pressure monitoring kit.
Cook Medical said customers and distributors should quarantine and discontinue use of all affected units, and return them to the company for credit.
If youâ€™ve been injured or hurt due to any of the catheters, trays, or sets that is on this recall list, please contact the attorneys at Chhabra & Gibbs, P.A., at 601-948-8005 or by going to our website at http://www.cglawms.com . We might be able to help you receive compensation allowed by law for damages or injuries. It doesnâ€™t cost you anything to call and talk to an attorney to see what options you have.