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.
July 22, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset, REF: A120-160X2YB
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: A120-161XPSV
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: A100-163XESF
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: A120-161XYBS
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: A120-161XYB
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: A120-160XYSF
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: A100-163XSFL
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: A120-112XSFK
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: A120-160XSFK
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: A120-161XPS
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: A100-163XES
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: A100-163XESV
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: A120-160XPS
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 BodySet, REF: A120-160SAS
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
May 13, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage:
Hazard: The filter installed onto the tube set may have the incorrect pore size.
March 25, 2020Medical DevicesFDA
CME America, LLC recalls CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpr
Hazard: 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) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)
March 18, 2020Medical DevicesFDA
CME America, LLC recalls BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: T
Hazard: When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
February 25, 2015Medical DevicesFDA
CME America, LLC recalls BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Hazard: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.