A Cook Central Venous Catheter recall has been issued for specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fracture and/or separation. While no reports of injury or illness have been reported to date, potential adverse events may occur as a result of catheter tip fracture, including stroke, kidney injury, or damage to the intestines or limbs. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer.
For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Cook Central Venous Catheter recall lawyer who can assist you throughout the legal process.
What is a Single Lumen Central Venous Catheter?
Single Lumen Central Venous Catheter Sets and Trays are designed for use in venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids. Central venous catheters are usually placed into a large vein in the neck, chest or groin.
Cook Central Venous Catheter Recall
According to a U.S. Food and Drug Administration (FDA) recall notice, Cook Medical has issued 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. Over 17,800 devices are subject to the recall worldwide. 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.
Investigation into the defective device revealed that the technique used by the product assembler likely contributed to the potential for catheter tip fracture and/or separation. Potential adverse events that may occur include:
- Loss of device function
- Need for medical intervention to retrieve a separated segment
- Complications resulting the prevention of blood flow due to a separated tip, including stroke, kidney injury, or damage to the intestines or limbs
Recalled devices were distributed globally from April 24, 2015 to October 23, 2015. Products can be identified by the part number and lot number that are provided on the outer package product label. A full list of lot numbers affected by this recall can be found here.
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 United States of America.
Who is Affected and What Should They Do?
Cook Medical notified all customers and distributors by recall notification letter in January 2016. All customers and distributors are advised to quarantine and stop use of all affected units and return them to the company as soon as possible.
How a Cook Central Venous Catheter Recall Lawyer Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective catheters may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
For more information, contact Attorney Group. After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.
