A brand of catheter used by physicians to monitor a patient’s vein pressure for blood sampling and administration of drugs and fluids, is being recalled by the manufacturer because of a defect that may cause patients serious injury and even death.
The recall involves Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays and Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays made by Excelsior Medical. These kits and trays contain 0.9 percent Sodium Chloride Injection USP 5mL fill in 6 mL flush syringes.
Leaks in the plunger leur were detected during a routine syringe leak test. This creates a potential for leakage and possible loss of sterility. Because this may cause serious adverse health consequences and/or death, the recall is classified as a Class 1, the most serious type of recall issued by the Food and Drug Administration (FDA).
Hospitals and health care facilities who are customers of Excelsior Medical have been informed of the recall and asked to examine their inventory for the defective devices. Meanwhile, any side effects with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.