Minneapolis-based Smiths Medical recalled nearly 20 million medical devices after two deaths, 25 injuries and 10,672 incidents were reported, the FDA said Feb. 2.
In a Class I recall — the most serious type — more than 19.7 million Continuous Ambulatory Delivery Device administration sets and medication cassette reservoirs were pulled from the market in December for two potential issues. A tubing blockage that could stop or under deliver medication has been tied to two deaths, 14 injuries and 1,571 incidents.
The second potential issue is a false "no disposable attached" alarm that prevents use of the pumps. This issue may lead to a delay of therapy, which can cause serious patient harm or death, the FDA said. There are 11 injuries and 9,101 incidents related to this problem.
For the recall, Smiths Medical recommended pharmacists and providers use alternative CADD infusion sets "for life-sustaining medications."