ICU Medical ConMed Stat2 Flow Controller Recalled (Class I) Because it Delivers Higher Flow Rate than Intended

Risk Managers and Biomedical Engineering personnel are informed by the FDA that the ICU Medical ConMed Stat2 Flow Controller is recalled because it was assembled with the wrong internal component.

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Background of Stat2 Flow Controller

IV administration sets are used for the delivery or removal of fluids from the body; a flow controller controls the amount of fluid delivered.

FDA Alert on ICU Medical ConMed Stat2 Flow Controller

FDA’s reason for the recall is that the Stat2 Flow Controller was assembled with the wrong internal component and it may deliver fluid at a much higher flow rate than what is set.

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. Their manufacture dates were from October, 2013 to January, 2014 and their distribution dates from October, 2013 to January, 2014.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

FDA Recommendation on ICU Medical ConMed Stat2 Flow Controller

“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 protected]

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