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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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