CareFusion 303 Recalls

Hazard: CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.

Hazard: CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

Hazard: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

Hazard: Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.

Hazard: An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.

Hazard: CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.

Hazard: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

Hazard: CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c

Hazard: CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

Hazard: Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

Hazard: CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

Hazard: CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

Hazard: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

Hazard: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

Hazard: CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

Hazard: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

Hazard: CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

Hazard: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.

Hazard: CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

Hazard: CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.

Hazard: The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly

Hazard: The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.

Hazard: The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.