FDA Class I Recall
CareFusion Alaris Syringe Pump (A Small Infusion Pump)
A recall has been issued for the CareFusion Alaris Syringe Pump.
- Affected Product Codes
- Alaris Syringe Pump, Model No. 8110
- Manufactured from: March 2014 to September 2014
- Distributed from: March 17, 2014 to September 30, 2014
- Devices Recalled in the U.S.: 6,458
A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.
Problems: Reason for Recall
An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Last Updated: 2015-08-28