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| Alaris Syringe infusion pump. Model 8110--Courtesy of CareFusion |
CareFusion is recalling 7,418 units of its Alaris Syringe infusion pump, a corrective action that the FDA just deemed Class 1. This marks CareFusion's ninth Class 1 recall of an Alaris device since 2010, according to the database.
Class 1 recalls are reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The worldwide recall covers devices of model 8110 manufactured between March 2014 and September 2014, and located in the U.S., Australia, South Africa, Canada and Taiwan, among other countries.
"CareFusion has identified an issue with the Alaris Syringe Pump module 8110 because the channel error will cause an audible and visual alarm on the Alaris PC unit and a channel error on the Alaris Syringe," the FDA said in its recall notice.
CareFusion will replace the syringe drive train assembly on the affected units. The notice also lists the affected product codes.
In April 2014, a whopping 57,219 units of model 8110 were recalled because of a software issue that would cause the device to not properly delay infusion when the "Delay Until" option is used, the FDA database says.
Previous recalls have included other Alaris model numbers, including 8000 and 8015, which recalled in December 2013 because they produced audible alarms and error messages.
There have also been 5 less severe Class 2 recalls since 2010.
- read the recall notice from the FDA
- here's more about the other recalls