CME America, LLC: Medical Device Recall in 2020 - (Recall #: Z-1474-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 7, 2020

Date Posted: March 25, 2020

Recall Number: Z-1474-2020

Event ID: 85033

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)

Status: Terminated

Product Quantity: 30,596 pumps

Code Information:

All serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated