Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2723-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Reason: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a p...
Z-2740-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2720-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2722-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2718-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Reason: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a p...
Z-2741-2020August 12, 2020San Diego, CA
CareFusion 303, Inc.
Class ITerminated
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Reason: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infus...
Z-2716-2020August 12, 2020San Diego, CA
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A100-163XE90S
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2573-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard set with Female Luer, REF: A120-003XSN
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2582-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-160XPS
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2554-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-161XPS
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2557-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A100-163XESV
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2555-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-160GCFA
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2577-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2581-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2589-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Filter, REF: A120-160XSFE
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2571-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-112XSFK
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2559-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2567-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-125XSE
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2576-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Sets, REF: A120-160C2YRV
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2579-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2587-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard BodySet, REF: A120-160SAS
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2553-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2583-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-160XSFK
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...
Z-2558-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Filter, REF: A100-164XESF
Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion o...