CareFusion is recalling the Alaris Syringe Pump due to a faulty Air-In-Lin (AIL) sensor, which may trigger a false alarm and cause the syringe pump to stop supplying infusion to the patient. A faulty AIL sensor could cause an interruption of infusion, which could lead to serious adverse health consequences or death.
The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. which is reserved for drugs and medical devices whose use may cause serious injury or death.
The recall affects the Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits with the Product numbers 147083 or 49000221. A total of 349,746 units are involved in the recall.
The Alaris Syringe Pump is used to deliver fluids such as nutrients, blood and medications into a patient’s body in controlled amounts. The syringe holds the solution, and the infusion tubing connects the syringe to the patient through intravenous or external access. It is used in adult, pediatric, and infant patients, and is only used in hospitals or other health care facilities.
CareFusion has contacted its hospital and health care facility customers and informed them of the recall. Any quality control issues or adverse events associated with this recalled product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.