The company noted that the affected Thermoset products included its room-temperature closed-loop drug-delivery system with an in-line temperature probe, as well as its Iced Thermoset system designed for cold injectate.
ICU Medical’s investigation found that a defect in the thermoset check valve component used in affected lots may cause leakages.
“A set with this defect can result in leakage of sterile solution, clinically significant blood loss, air embolism or systemic infection,” the company wrote.
ICU Medical noted that it has not received any reports of adverse events related to this defect. The company requested that customers stop the use and distribution of the affected product immediately.
“ICU Medical implemented corrective actions to correct the manufacturing process that led to the minor defects in the thermoset check valve,” the company added.
ICUI shares were trading at $261.28 apiece in mid-afternoon activity today, down -1.8%.