CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric, despite the source text not explicitly reporting injuries or deaths.
Plain-English summary
CME America, LLC is recalling all models of the BodyGuard Infusion Pump System, including BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress. The recall affects 30,596 pumps distributed across 43 U.S. states and the District of Columbia. All serial numbers are included in this recall.
The recall is due to a potential delivery inaccuracy of up to 13 percent. This inaccuracy may result in faster than expected drug delivery when infusing at a very low rate of 0.1 mL/h, or slower than expected drug delivery when infusing at high flow rates greater than 500 mL/h. The agency has classified this as a Class I recall.
Healthcare facilities and users should stop using the affected pumps and contact CME America for further instructions on replacement or repair. The source text does not specify a particular action for individual consumers, as these devices are typically used in clinical settings.
The recalled product
- Product
- CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 30,596
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Related recalls
Same manufacturer · CME America, LLC
See all →- HighCME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump Recalled for Motor Wear and Fluid Damage
FDA (Devices) · 2020-12-09
- HighCME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
FDA (Devices) · 2020-12-09
- HighCME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
FDA (Devices) · 2020-12-09
- SevereCME America Recalls NeoThrive Syringe Pumps Due to Motor Wear
FDA (Devices) · 2020-12-09
Same hazard · medication dosing error
See all →- HighBD Pyxis automated dispensing cabinets recalled for software dosing bug
FDA (Devices) · 2025-04-16
- HighMedical device assay may report falsely elevated lithium levels
FDA (Devices) · 2022-10-26
- HighMOSAIQ Oncology Information System software defect reverts approved drug strength
FDA (Devices) · 2021-10-06
- HighCareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations
FDA (Devices) · 2017-10-25
- SevereAlere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results
FDA (Devices) · 2016-08-31
Similar recalls
- SevereCME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk
FDA (Devices) · 2015-02-25
- CriticalCME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22
- SevereCME America BodyGuard Infusion Sets Recalled for Delivery Inaccuracy
FDA (Devices) · 2020-07-22