# FDA recall Z-2575-2020

> **CME America, LLC** · Class I · device recall initiated 2020-06-16.

## Product

BodyGuard Microset, REF: A120-003XS2YV

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2575-2020
- **Recalling firm:** CME America, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-16
- **Report date:** 2020-07-22
- **Termination date:** 2022-05-09

- **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-2575-2020

## Citation

> AI Analytics. FDA recall Z-2575-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2575-2020. Source: US FDA. Licensed CC0.

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