CME America BodyGuard Infusion Pump System — Class I medical device recall Z-1474-2020
Terminated recall by CME America, LLC, reported 2020-03-25, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected
| Recall number | Z-1474-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CME America, LLC, Golden, CO, United States |
| Recall initiated | 2020-01-07 |
| Classified | 2020-03-18 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2022-04-14 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY |
| Quantity | 30,596 pumps |
| Model numbers | 121, 323, 545, 575, CV545, CV575 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1474-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.