FDA recall Z-1474-2020

CME America, LLC · Class I · device

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

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

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