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-2556-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-161XYBS
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-2563-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-160X2YB
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-2566-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A100-163XSFL
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-2560-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Sets, 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-2578-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
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-2584-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset with Filter, REF: A100-163XESF
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-2564-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-003XS2YV
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-2575-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A100-163XSL
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-2574-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Set, REF: A120-160C
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-2586-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Sets, REF: A120-161C
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-2580-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Set, REF: A120-160CRV
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-2568-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-160XYSF
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-2561-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset With Female Luer, REF: A120-160XPSN
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-2588-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-161XYB
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-2562-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
CMExpress Microbore Set, REF: A120-161CYF
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-2569-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset, REF: A120-161XPSV
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-2565-2020July 22, 2020Golden, CO
CME America, LLC
Class ITerminated
Standard BodySet with Needleless Connectors, REF: A120-125XS
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...
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-2570-2020July 22, 2020Golden, CO
CME America, LLC
Class IITerminated
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA the...
Reason: The filter installed onto the tube set may have the incorrect pore size.
Z-1886-2020May 13, 2020Golden, CO
CME America, LLC
Class ITerminated
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Reason: Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slow...
Z-1474-2020March 25, 2020Golden, CO
CME America, LLC
Class ITerminated
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids ...
Reason: When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Z-1442-2020March 18, 2020Golden, CO
Flowonix Medical Inc
Class IIOngoing
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1120-2020February 19, 2020Mansfield, MA
Flowonix Medical Inc
Class IIOngoing
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1123-2020February 19, 2020Mansfield, MA
Medtronic Inc.
Class IOngoing
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
Reason: There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that pre...