ICU Medical has issued a Class I recall for certain 150 mL IV Gravity Burette Sets after discovering some devices are missing an internal shut-off valve, increasing the risk of uncontrolled fluid flow.
The recall affects two types of 23-inch burette sets, affecting three product lots, according to a Dec. 30 news release from the FDA. The missing valve may lead to overdelivery, air infusion, delayed therapy or unrestricted flow, potentially resulting in serious harm or death.
The manufacturer first notified customers of the issue Oct. 2. As of Sept. 25, no serious injuries or fatalities had been reported.
The FDA advised users to identify and discontinue use of affected products, destroy them per facility protocol or quarantine until disposal. The agency also instructed that all potential users, including those at off-site locations, be notified.
The recalled products are single-use administration sets intended to deliver fluids intravenously.
