AUDIENCE: Risk Manager, Biomedical Engineering
ISSUE: FDA notified health professionals and their medical care organizations of a Class 1 recall of the Stat2 Flow Controller because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow rate than what is set. Use of the affected product may cause serious adverse health consequences, including death.
BACKGROUND: IV administration sets are used to deliver or remove fluids from the body, with the amount of fluid delivered controlled by a flow controller. The affected item numbers: 011-C9801, 011-C9802, AH7007, B9897, Z2648 and affected lot numbers: 2768416, 2768417, 2758229, 2785379, 2801951, 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL. The recalled product was manufactured from October, 2013 to January, 2014 and distributed from October, 2013 to January, 2014.
RECOMMENDATIONS: On August 19, 2014, ICU Medical Inc. sent an Urgent Medical Device Recall Notification letter to affected customers and authorized distributors. The letter identified the affected product, problem and actions to be taken. The letter advised customers to remove the affected devices from use and return them to ICU Medical, Inc. Questions about this recall may be directed to ICU Customer Service at 866-829-9025 (Option 8), Monday through Friday, 8:30 AM - 4:00 PM Pacific Time or e-mail email@example.com.
[10/10/2014 - Recall Notice - FDA]