CME America Recalls
48 recalls on record · February 25, 2015 to December 9, 2020 · Medical Devices
Recalls by year
15
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring cont
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermit
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermi
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or interm
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
December 9, 2020Medical DevicesFDA
CME America, LLC recalls CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent
Hazard: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
November 4, 2020Medical DevicesFDA
CME America LLC recalls CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/
Hazard: The wall charger may not properly charge the infusion pump battery.
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset With Female Luer, REF: A120-160XPSN
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Set, REF: A120-160C
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls Standard BodySet with Needleless Connectors, REF: A120-125XS
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard set with Female Luer, REF: A120-003XSN
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Sets, REF: A120-161C
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Sets, REF: A120-160C2YRV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Sets, REF: A120-160CYFRV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A120-160GCFA
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A120-125XSE
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A120-003XS2YV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A100-163XSL
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A100-163XE90S
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset with Filter, REF: A100-164XESF
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset with Filter, REF: A120-160XSFE
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Set, REF: A120-161CYF
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls CMExpress Microbore Set, REF: A120-160CRV
Hazard: 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 or under-infusion of therapy
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Hazard: 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 or under-infusion of therapy