Cook Medical Catheters, Trays Recall Issued Over Broken Tips
Nearly 18,000 Cook Medical catheters and pressure monitoring sets and trays distributed worldwide have been recalled, due to a risk that the catheter tips may fracture or separate during use.
The Cook Medical catheter recall was announced by the FDA February 10. The products were recalled because of the potential for the catheter tips to fracture and/or separate during use. While there have been no reports of injury or illness connected to the products to date, this may cause a risk of severe complications for patients.
The products are used for venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids.
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Cook Medical investigators say they found that the catheter tips could fracture or separate from the catheter during an internal inspection. They determined the defect was likely caused by a manufacturing technique used by the product assembler while tipping the catheter.
If the tips break or separate, it may result in loss of device function, the need for medical intervention to retrieve a separated segment or tip, and complications resulting from the separated tip occluding blood flow to organs. This may result in stroke, kidney injury, or damage to the intestines or limbs in patients who use the product.
After discovering the defect, Cook Medical notified the FDA and other global regulatory agencies of the recall and problems.
The recall affects 360 specific lots of Cook Medical Central Venous Catheters and Pressure Monitoring Sets and Trays. Those products include specified 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. A full list of lot numbers and product numbers affected by the recall is available in the recall announcement.
Globally nearly 18,000 devices are subject to the recall that were sold in countries around the world. Shipments were made to Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, India, Israel, Italy, Jordan, Kuwait, Netherland, New Zealand, Panama, Puerto Rico, Spain, Switzerland, United Arab Emirates, United Kingdom, and the U.S.
Cook Medical notified its customers and distributors by issuing recall notification letters in January. The company recommends customers and distributors stop using the products immediately, and quarantine them from other stock to prevent future use.
Customers should return the affected products to the company as soon as possible and will receive a full refund.
The Cook Medical catheters were distributed globally between April 24, 2015, and October 23, 2015, and can be identified by the part number and lot number that are provided on the outer package product label.
Customers can find affected reference and lot numbers on the FDA website and can contact Cook Medical at 800-457-4500.
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