# FDA recall Z-1474-2020

> **CME America, LLC** · Class I · device recall initiated 2020-01-07.

## Product

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

## Reason for recall

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)

## Distribution

U.S.: HI, OR, AR, MA, PA, OH, WY, CO, NE, NC, WA, TX, UT, MD, CA, KY, FL, NH, TN, NY, SD, MO, IL, WI, MN, RI, VA, DC, SC, NJ, ME, KS, CT, MI, LA, AK, NM, IA, MT, ID, AZ, AL, VT, IN, MS

## Key facts

- **Recall number:** Z-1474-2020
- **Recalling firm:** CME America, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-07
- **Report date:** 2020-03-25
- **Termination date:** 2022-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Golden, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1474-2020

## Citation

> AI Analytics. FDA recall Z-1474-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1474-2020. Source: US FDA. Licensed CC0.

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