Medical Devices

Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Photo of Single Lumen Central Venous Catheter Sets & Trays

Single Lumen Central Venous Catheter Sets & Trays


Photo of Single Lumen Pressure Monitoring Sets & Trays

Single Lumen Pressure Monitoring Sets & Trays


Photo of Femoral Artery Pressure Monitoring Catheter Sets and Trays

Femoral Artery Pressure Monitoring Catheter Sets and Trays

Recalled Product(s):

  • Single Lumen Central Venous Catheter Sets & Trays; Single Lumen Pressure Monitoring Sets & Trays; Femoral Artery Pressure Monitoring Catheter Sets & Trays; Radial Artery Pressure Monitoring Catheter Sets & Trays
  • Lot Numbers: See complete list of lot numbers heredisclaimer icon
  • Manufacturing Dates: April 9, 2015 to October 22, 2015
  • Distribution Dates: April 24, 2015 to October, 23, 2015
  • Devices Recalled in the U.S.: 12,516 nationwide, including Washington, D.C. and Puerto Rico

Device Use

These devices are used to monitor pressure in a patient’s vein or artery, to sample blood, and to administer drugs or fluids.

Reason for Recall

Cook Medical is recalling these devices because the tips may split or separate from the catheters due to a manufacturing error. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.

Who May be Affected

  • All patient groups undergoing procedures involving these catheters

What to Do

On January 6, 2016, Cook Medical sent their customers an urgent medical device recall letter. The letter instructed customers to:

  • Review the list of affected products and lot numbers
  • Immediately quarantine unused products from their inventory
  • Collect and return all unused products to Cook Medical as soon as possible
  • Complete the Recall Response Form attached to the letter and return it to Cook Medical
  • Report any adverse events to Cook Medical Customer Relations 800-457-4500 or 812-339-2235, Monday through Friday between 7:30 a.m. and 5:00 p.m., Eastern Time or to FieldActionsNA@cookmedical.com
  • Adverse events or quality problems experienced with use of the product may also be reported to the FDA

Date Recall Initiated:

January 6, 2016

Page Last Updated: 03/31/2016
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