Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays and Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays are being recalled, the U.S. Food and Drug Administration (FDA) just announced. Cook, Inc., located at 750 Daniels Way â€¨Bloomington, Indiana 47404-9120, is conducting the Venous Catheter Tray recall.
This is a Class I recall. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
These recalled medical devices were manufactured from December 4, 2008 through May 1, 2009 and were distributed from January 1, 2009 through September 30, 2010.
The defective medical devices are meant for use by physicians to monitor a patientâ€™s pressure in a vein, for blood sampling, and administration of drugs and fluids.
These kits and trays contain a 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that were recalled by Excelsior Medical. Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. Device failure of the Excelsior Disposable saline flush syringes could result in an infection in the bloodstream, which may result in serious injury or death.
Cook Customer Relations Department can be reached, toll-free, at 1.800.457.4500 or by FAX at 1.800.544.8335, Eastern Time.
On October 4, 2010, Cook Inc. sent Urgent Device Recall letters to its customers asking customers to examine their inventory and notify Cook about returning these recalled products. The letter included a response form.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.